What Jobs are available for Pharmaceutical Engineer in Bahrain?
Showing 5000+ Pharmaceutical Engineer jobs in Bahrain
Senior Pharmaceutical Process Engineer
4102 Hamad Town, Northern
BHD98000 Annually
WhatJobs Direct
Posted today
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Job Description
Our client, a dynamic pharmaceutical company at the forefront of drug development and manufacturing, is seeking a highly experienced Senior Pharmaceutical Process Engineer to join their fully remote operations team. This pivotal role will involve the design, optimization, and validation of manufacturing processes for pharmaceutical products, ensuring compliance with stringent regulatory standards (e.g., cGMP). You will leverage your expertise in chemical engineering, biotechnology, and process control to improve efficiency, yield, and product quality. This is a remote-first position, requiring excellent virtual collaboration and project management skills.
Responsibilities include developing process flow diagrams (PFDs) and piping and instrumentation diagrams (P&IDs), conducting process hazard analyses (PHAs), and performing validation studies (IQ/OQ/PQ). You will also be involved in troubleshooting production issues, implementing process improvements, and managing technology transfer projects. The ideal candidate will possess a Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related discipline, with a minimum of 7 years of relevant experience in the pharmaceutical industry. A strong understanding of aseptic processing, lyophilization, filtration, and upstream/downstream bioprocessing is crucial. Experience with process simulation software (e.g., Aspen Plus, SuperPro Designer) and statistical analysis tools is highly valued. You must be adept at working independently, communicating complex technical information clearly, and contributing to a collaborative team environment despite the remote setting. The successful candidate will play a key role in bringing life-saving medications to market through efficient and robust manufacturing processes. We are looking for a proactive individual with a strong commitment to quality and safety, and a passion for innovation in pharmaceutical manufacturing. This role offers a unique opportunity to contribute to impactful projects from a remote location, driving advancements in pharmaceutical production.
Responsibilities include developing process flow diagrams (PFDs) and piping and instrumentation diagrams (P&IDs), conducting process hazard analyses (PHAs), and performing validation studies (IQ/OQ/PQ). You will also be involved in troubleshooting production issues, implementing process improvements, and managing technology transfer projects. The ideal candidate will possess a Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related discipline, with a minimum of 7 years of relevant experience in the pharmaceutical industry. A strong understanding of aseptic processing, lyophilization, filtration, and upstream/downstream bioprocessing is crucial. Experience with process simulation software (e.g., Aspen Plus, SuperPro Designer) and statistical analysis tools is highly valued. You must be adept at working independently, communicating complex technical information clearly, and contributing to a collaborative team environment despite the remote setting. The successful candidate will play a key role in bringing life-saving medications to market through efficient and robust manufacturing processes. We are looking for a proactive individual with a strong commitment to quality and safety, and a passion for innovation in pharmaceutical manufacturing. This role offers a unique opportunity to contribute to impactful projects from a remote location, driving advancements in pharmaceutical production.
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0
Senior Pharmaceutical Process Engineer
1071 Askar, Southern
BHD110000 Annually
WhatJobs
Posted 1 day ago
Job Viewed
Job Description
Our client, a rapidly growing pharmaceutical innovator, is seeking an experienced Senior Pharmaceutical Process Engineer to join their remote team. This role is critical in optimizing and scaling up manufacturing processes for life-saving medications. You will be responsible for designing, validating, and troubleshooting complex chemical and biological processes, ensuring compliance with stringent regulatory standards (FDA, EMA). This fully remote position requires a blend of theoretical knowledge and practical application, focusing on process improvements, yield enhancement, and cost reduction. You will collaborate with research and development, quality assurance, and manufacturing teams to ensure a smooth transition from laboratory scale to commercial production. Responsibilities include:* Designing, optimizing, and scaling up pharmaceutical manufacturing processes.
* Developing and executing validation protocols for new and existing processes.
* Troubleshooting process deviations and implementing corrective actions.
* Conducting feasibility studies and risk assessments for process changes.
* Ensuring compliance with cGMP, FDA, and other relevant regulatory guidelines.
* Collaborating with cross-functional teams, including R&D, QA/QC, and Manufacturing.
* Generating process documentation, including SOPs and batch records.
* Identifying opportunities for process improvement and cost reduction.
* Mentoring junior engineers and technical staff.
The ideal candidate will hold a Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, or a related field, with a minimum of 7 years of experience in pharmaceutical process development and scale-up. Deep understanding of cGMP regulations and experience with process validation are essential. Strong analytical, problem-solving, and project management skills are required. Excellent written and verbal communication skills are necessary for effective remote collaboration. Proficiency in process simulation software and statistical analysis tools is highly desirable. This is an excellent opportunity to contribute to the advancement of pharmaceutical manufacturing from a remote setting.
* Developing and executing validation protocols for new and existing processes.
* Troubleshooting process deviations and implementing corrective actions.
* Conducting feasibility studies and risk assessments for process changes.
* Ensuring compliance with cGMP, FDA, and other relevant regulatory guidelines.
* Collaborating with cross-functional teams, including R&D, QA/QC, and Manufacturing.
* Generating process documentation, including SOPs and batch records.
* Identifying opportunities for process improvement and cost reduction.
* Mentoring junior engineers and technical staff.
The ideal candidate will hold a Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, or a related field, with a minimum of 7 years of experience in pharmaceutical process development and scale-up. Deep understanding of cGMP regulations and experience with process validation are essential. Strong analytical, problem-solving, and project management skills are required. Excellent written and verbal communication skills are necessary for effective remote collaboration. Proficiency in process simulation software and statistical analysis tools is highly desirable. This is an excellent opportunity to contribute to the advancement of pharmaceutical manufacturing from a remote setting.
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1
Principal Pharmaceutical Process Engineer
226 Saar, Northern
BHD110000 Annually
WhatJobs
Posted 9 days ago
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Job Description
Our client is seeking a highly experienced and innovative Principal Pharmaceutical Process Engineer to lead the design, optimization, and scale-up of pharmaceutical manufacturing processes. This fully remote role allows you to leverage your extensive expertise to make a significant impact on drug production from anywhere. You will be responsible for developing and implementing robust, efficient, and compliant manufacturing processes for a wide range of pharmaceutical products, ensuring adherence to strict regulatory guidelines (e.g., cGMP). Your duties will include process design and development, troubleshooting manufacturing issues, conducting validation studies, and improving existing processes to enhance yield, quality, and cost-effectiveness. You will work closely with cross-functional teams, including R&D, Quality Assurance, and Operations, to ensure seamless technology transfer and successful commercialization of new products. The ideal candidate will possess a Master's or Ph.D. in Chemical Engineering or a related field, with a deep understanding of pharmaceutical manufacturing principles, sterile processing, and bioprocessing. Proven experience in process scale-up, optimization, and validation is essential. Strong analytical, problem-solving, and project management skills are required, along with excellent communication and leadership abilities to guide and mentor process engineering teams remotely. You will be instrumental in driving innovation in manufacturing technologies, implementing lean manufacturing principles, and ensuring the highest standards of quality and safety. This role requires a proactive approach to identifying and mitigating risks, optimizing resource utilization, and driving continuous improvement initiatives. You will also play a key role in regulatory submissions and inspections. This is a critical position for a seasoned professional looking to shape the future of pharmaceutical manufacturing processes and contribute to the availability of life-saving medications. While the role is remote, familiarity with operational challenges faced by companies in the pharmaceutical sector near Saar, Northern, BH would be beneficial.
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2
Lead Pharmaceutical Process Engineer
20420 Askar, Southern
BHD88000 Annually
WhatJobs
Posted 10 days ago
Job Viewed
Job Description
Our client, a leading innovator in the pharmaceutical manufacturing sector, is seeking a highly skilled and experienced Lead Pharmaceutical Process Engineer to join their dynamic team in Sitra, Capital, BH . This critical role involves optimizing and developing robust pharmaceutical manufacturing processes to ensure efficiency, quality, and compliance with global regulatory standards. The Lead Engineer will be instrumental in driving process improvements, implementing new technologies, and ensuring the seamless scale-up of production from pilot to commercial stages. The ideal candidate will possess a strong foundation in chemical engineering principles applied to pharmaceutical production and a proven ability to lead complex engineering projects.
Key Responsibilities:
Key Responsibilities:
- Design, develop, optimize, and scale-up pharmaceutical manufacturing processes, including formulation, granulation, tablet compression, coating, and packaging.
- Lead process validation activities, including protocol development, execution, and report writing in accordance with cGMP guidelines.
- Troubleshoot and resolve process-related issues, identifying root causes and implementing effective corrective and preventive actions (CAPAs).
- Develop and maintain Standard Operating Procedures (SOPs) for all manufacturing processes.
- Conduct process hazard analyses (PHAs) and ensure compliance with all safety regulations.
- Evaluate and recommend new process technologies and equipment to enhance efficiency, quality, and cost-effectiveness.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Manufacturing Operations, to ensure successful process implementation and technology transfer.
- Provide technical expertise and guidance to junior engineers and manufacturing personnel.
- Monitor key process performance indicators (KPIs) and implement strategies for continuous improvement.
- Ensure all process documentation is meticulously maintained and compliant with regulatory requirements.
- Stay current with industry trends, new technologies, and regulatory updates relevant to pharmaceutical manufacturing.
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3
Senior Pharmaceutical Process Engineer
603 Zallaq, Southern
BHD95000 Annually
WhatJobs
Posted 15 days ago
Job Viewed
Job Description
Our client, a pioneering pharmaceutical company, is seeking an exceptionally talented and experienced Senior Pharmaceutical Process Engineer to join their groundbreaking, fully remote research and development division. This role offers a unique chance to drive innovation in pharmaceutical manufacturing processes without the constraints of a traditional office environment. You will be responsible for the design, development, optimization, and validation of complex pharmaceutical manufacturing processes, ensuring compliance with stringent regulatory standards such as GMP (Good Manufacturing Practice). Your duties will encompass evaluating new technologies, troubleshooting existing processes, and implementing improvements to enhance efficiency, yield, and product quality. A significant part of your work will involve detailed process modeling, simulation, and data analysis to identify critical process parameters and ensure robustness. You will collaborate extensively with cross-functional teams, including R&D scientists, quality assurance, and regulatory affairs, to translate laboratory discoveries into commercially viable manufacturing solutions. The ideal candidate will possess a deep understanding of chemical engineering principles as applied to pharmaceutical production, including sterile manufacturing, lyophilization, and drug formulation. Experience with aseptic processing and a strong grasp of validation strategies (IQ, OQ, PQ) are crucial. We are looking for a proactive, results-oriented professional with superior analytical and problem-solving skills, who excels in a self-directed, remote setting. This is a critical position for shaping the future of pharmaceutical manufacturing. The designated work hub for this position is in Zallaq, Southern, BH , however, the role is entirely remote.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Design, develop, and optimize pharmaceutical manufacturing processes.
- Ensure compliance with cGMP, FDA, and other regulatory requirements.
- Conduct process hazard analyses and implement safety measures.
- Perform process simulations and modeling to optimize parameters.
- Troubleshoot manufacturing issues and implement corrective actions.
- Develop validation master plans and execute validation protocols (IQ, OQ, PQ).
- Collaborate with R&D, QA/QC, and regulatory affairs teams.
- Evaluate and implement new manufacturing technologies.
- Author and review process development reports and technical documentation.
- Train and mentor junior engineers and technical staff.
Qualifications:
- Master's or Ph.D. in Chemical Engineering, Pharmaceutical Engineering, or a related field.
- Minimum of 8 years of experience in pharmaceutical process development and engineering.
- Extensive knowledge of GMP regulations and guidelines.
- Proven experience in sterile manufacturing, aseptic processing, or biologics manufacturing.
- Expertise in process validation, scale-up, and technology transfer.
- Proficiency in process modeling and simulation software.
- Strong analytical, problem-solving, and project management skills.
- Excellent communication and interpersonal abilities.
- Ability to work independently and thrive in a remote work environment.
- Experience with specific dosage forms (e.g., injectables, oral solids, biologics).
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4
Senior Chemical Process Engineer - Pharmaceutical Manufacturing
67890 Galali
BHD150000 Annually
WhatJobs
Posted 17 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical manufacturing company, is seeking a highly experienced and innovative Senior Chemical Process Engineer to join their state-of-the-art facility. This role will be based in **Sanad, Capital, BH**, with a flexible hybrid work arrangement, allowing for both on-site collaboration and remote work. You will be responsible for the design, development, optimization, and troubleshooting of chemical processes critical to the production of life-saving pharmaceuticals.
The successful candidate will play a pivotal role in scaling up laboratory processes to pilot and commercial manufacturing. You will conduct detailed process hazard analyses, develop standard operating procedures (SOPs), and ensure compliance with stringent regulatory requirements (e.g., GMP). Your expertise in chemical kinetics, thermodynamics, fluid dynamics, and mass transfer will be leveraged to improve process efficiency, yield, and product quality. You will work collaboratively with R&D, engineering, manufacturing, and quality assurance teams to ensure seamless project execution and continuous improvement. Strong project management skills and the ability to lead cross-functional teams are essential for success in this role.
Key Responsibilities:
The ideal candidate will hold a Bachelor's or Master's degree in Chemical Engineering. A minimum of 7 years of experience in chemical process engineering, preferably within the pharmaceutical or biotech industry, is required. Demonstrated experience in process scale-up, optimization, and validation is essential. Strong knowledge of GMP regulations and experience with process hazard analysis (PHA) techniques are highly desirable. Proficiency in process simulation software (e.g., Aspen Plus, HYSYS) and CAD tools is expected. Excellent analytical, problem-solving, and project management skills are paramount. Strong written and verbal communication abilities are necessary for effective collaboration and reporting. The ability to work effectively in a hybrid environment, balancing on-site and remote responsibilities, is crucial. This is an excellent opportunity to contribute to critical pharmaceutical manufacturing processes.
The successful candidate will play a pivotal role in scaling up laboratory processes to pilot and commercial manufacturing. You will conduct detailed process hazard analyses, develop standard operating procedures (SOPs), and ensure compliance with stringent regulatory requirements (e.g., GMP). Your expertise in chemical kinetics, thermodynamics, fluid dynamics, and mass transfer will be leveraged to improve process efficiency, yield, and product quality. You will work collaboratively with R&D, engineering, manufacturing, and quality assurance teams to ensure seamless project execution and continuous improvement. Strong project management skills and the ability to lead cross-functional teams are essential for success in this role.
Key Responsibilities:
- Design, develop, and optimize chemical processes for pharmaceutical manufacturing.
- Scale up chemical processes from laboratory to pilot plant and commercial production.
- Conduct process simulations, mass and energy balances, and P&ID development.
- Perform process hazard analyses (PHAs) and implement safety protocols.
- Develop and validate SOPs and batch records for manufacturing operations.
- Troubleshoot and resolve process-related issues in production.
- Identify and implement opportunities for process improvement and cost reduction.
- Collaborate with R&D, quality control, and regulatory affairs teams.
- Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory standards.
- Mentor junior process engineers and provide technical guidance.
The ideal candidate will hold a Bachelor's or Master's degree in Chemical Engineering. A minimum of 7 years of experience in chemical process engineering, preferably within the pharmaceutical or biotech industry, is required. Demonstrated experience in process scale-up, optimization, and validation is essential. Strong knowledge of GMP regulations and experience with process hazard analysis (PHA) techniques are highly desirable. Proficiency in process simulation software (e.g., Aspen Plus, HYSYS) and CAD tools is expected. Excellent analytical, problem-solving, and project management skills are paramount. Strong written and verbal communication abilities are necessary for effective collaboration and reporting. The ability to work effectively in a hybrid environment, balancing on-site and remote responsibilities, is crucial. This is an excellent opportunity to contribute to critical pharmaceutical manufacturing processes.
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5
Senior Process Engineer - Pharmaceutical Manufacturing
234 BH Tubli
BHD75000 Annually
WhatJobs
Posted 6 days ago
Job Viewed
Job Description
Our client is seeking a highly skilled and experienced Senior Process Engineer to oversee and optimize manufacturing processes within their state-of-the-art pharmaceutical facility. This role is based in our facility located in Isa Town, Southern, BH . You will be responsible for designing, implementing, and improving chemical and mechanical processes to ensure efficiency, safety, and product quality. This position requires a strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements specific to the pharmaceutical industry. The Senior Process Engineer will play a critical role in troubleshooting production issues, identifying opportunities for cost reduction and yield improvement, and leading process validation activities. You will collaborate closely with production, quality assurance, and R&D teams to translate new product requirements into scalable manufacturing solutions. This involves detailed process mapping, hazard analysis, and the development of standard operating procedures (SOPs). The ideal candidate will possess excellent analytical skills, a proactive approach to problem-solving, and the ability to mentor junior engineers. Experience with process simulation software and statistical process control (SPC) methodologies is highly desirable. You will also be involved in capital expenditure projects, evaluating new equipment, and overseeing its installation and commissioning. This role demands a commitment to continuous improvement and a passion for driving operational excellence in a demanding manufacturing environment.
Key Responsibilities:
Key Responsibilities:
- Design, develop, and optimize manufacturing processes for pharmaceutical products.
- Ensure processes comply with GMP, FDA, and other relevant regulatory standards.
- Troubleshoot and resolve production-related issues to minimize downtime and maximize efficiency.
- Lead process validation activities, including IQ, OQ, and PQ.
- Develop and implement SOPs for all manufacturing processes.
- Collaborate with R&D and QA teams on new product introductions and process scale-up.
- Conduct process hazard analyses and implement risk mitigation strategies.
- Identify and implement cost-saving initiatives and yield improvement projects.
- Manage capital projects related to equipment upgrades and new installations.
- Mentor and guide junior process engineers.
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field.
- Minimum of 6 years of experience in process engineering within the pharmaceutical or biopharmaceutical industry.
- In-depth knowledge of GMP and regulatory compliance.
- Experience with process simulation and modeling software (e.g., Aspen Plus).
- Proficiency in statistical process control (SPC) and data analysis.
- Excellent problem-solving and analytical skills.
- Strong project management and leadership capabilities.
- Ability to communicate effectively with technical and non-technical stakeholders.
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6
Lead Process Engineer - Pharmaceutical Manufacturing
94107 Seef, Capital
BHD140000 Annually
WhatJobs
Posted 17 days ago
Job Viewed
Job Description
Our client, a cutting-edge pharmaceutical manufacturing company, is looking for a Lead Process Engineer to join their fully remote team. This role is critical for optimizing and innovating manufacturing processes to ensure the highest standards of quality, efficiency, and compliance in pharmaceutical production. The Lead Process Engineer will be responsible for designing, developing, and troubleshooting complex manufacturing processes, with a strong emphasis on aseptic processing, sterile manufacturing, and downstream purification. You will work closely with cross-functional teams, including R&D, Quality Assurance, and Operations, to implement process improvements, scale-up new products, and ensure adherence to GMP regulations. The ideal candidate will possess a deep understanding of chemical engineering principles, process modeling, and validation strategies. Experience with equipment such as bioreactors, chromatography systems, filtration units, and lyophilizers is highly desirable. This role requires excellent analytical skills to interpret process data, identify root causes of issues, and develop effective solutions. You will also be involved in selecting and implementing new process technologies and equipment. Strong project management skills are essential, as you will lead process development projects from conceptualization to commercialization. This is a fully remote position, offering the flexibility to work from anywhere while driving significant advancements in pharmaceutical manufacturing. We seek a proactive, results-oriented individual with a passion for scientific innovation and a commitment to patient safety. The ability to collaborate effectively with a distributed team and communicate complex technical information to diverse audiences is paramount.
Key Responsibilities:
Key Responsibilities:
- Lead the design, development, and optimization of pharmaceutical manufacturing processes.
- Troubleshoot and resolve complex process-related issues in manufacturing.
- Develop and implement process validation strategies and protocols.
- Oversee process scale-up activities from laboratory to commercial production.
- Collaborate with R&D, QA, and Operations teams to ensure seamless integration of new processes.
- Evaluate and recommend new process technologies and equipment.
- Ensure compliance with cGMP, FDA, and other regulatory requirements.
- Conduct process hazard analyses and implement safety measures.
- Mentor and guide junior process engineers.
- Prepare technical reports, documentation, and presentations.
- Master's degree or Ph.D. in Chemical Engineering or a related discipline.
- Minimum of 7 years of experience in process engineering within the pharmaceutical or biopharmaceutical industry.
- Expertise in aseptic processing, sterile manufacturing, or downstream processing.
- Strong understanding of GMP regulations and validation principles.
- Proficiency with process simulation and modeling software.
- Experience with pharmaceutical manufacturing equipment.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong project management and leadership abilities.
- Exceptional communication and interpersonal skills for remote collaboration.
- Ability to work independently and manage multiple priorities effectively.
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7
Senior Process Engineer - Pharmaceutical Manufacturing
7012 Isa Town, Northern
BHD85000 Annually
WhatJobs
Posted 17 days ago
Job Viewed
Job Description
Our client is a leading pharmaceutical manufacturer dedicated to producing high-quality medicines. We are seeking an experienced Senior Process Engineer to join our manufacturing operations team. This role is integral to optimizing production processes, ensuring efficiency, quality, and safety in our state-of-the-art facility in Isa Town, Southern, BH . The ideal candidate will possess a strong background in chemical or process engineering, with proven experience in pharmaceutical manufacturing environments. This is a hands-on position requiring strong analytical and problem-solving skills.
Responsibilities:
Responsibilities:
- Design, develop, implement, and optimize manufacturing processes for pharmaceutical products, ensuring compliance with cGMP standards.
- Troubleshoot production issues, identify root causes, and implement corrective and preventive actions (CAPA) to minimize downtime and improve yield.
- Conduct process validation and qualification activities, ensuring that equipment and processes meet required specifications.
- Develop and review Standard Operating Procedures (SOPs), batch records, and other manufacturing documentation.
- Collaborate with R&D, Quality Assurance, and Production teams to scale up new products and processes from laboratory to commercial production.
- Monitor key performance indicators (KPIs) for production processes and implement strategies for continuous improvement.
- Evaluate and recommend new technologies and equipment to enhance manufacturing capabilities and efficiency.
- Ensure adherence to all safety regulations and environmental policies within the manufacturing plant.
- Train production staff on new processes, equipment, and safety procedures.
- Participate in internal and external audits related to manufacturing processes and compliance.
- Prepare technical reports, cost analyses, and project proposals for process improvements.
- Maintain a strong understanding of pharmaceutical industry trends and regulatory requirements.
- Bachelor's degree in Chemical Engineering, Process Engineering, Mechanical Engineering, or a related field. A Master's degree is preferred.
- Minimum of 5-7 years of experience in process engineering, specifically within the pharmaceutical or biotechnology industry.
- Strong knowledge of cGMP (current Good Manufacturing Practices) regulations and validation principles.
- Experience with process simulation software and data analysis tools.
- Proficiency in troubleshooting manufacturing equipment and processes.
- Excellent analytical, problem-solving, and critical-thinking skills.
- Strong project management and organizational abilities.
- Effective communication and interpersonal skills, with the ability to collaborate across departments.
- Experience with aseptic processing, lyophilization, or other specialized pharmaceutical manufacturing techniques is a plus.
- This position requires full-time commitment at our facility in Isa Town, Southern, BH .
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8
Senior Process Engineer - Pharmaceutical Manufacturing
610 Isa Town, Northern
BHD95000 Annually
WhatJobs
Posted 22 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical manufacturer, is seeking a highly experienced Senior Process Engineer to join their dedicated team. This role requires a significant on-site presence at our facility located in **Isa Town, Southern, BH**, to actively participate in the development, optimization, and scale-up of manufacturing processes. You will be responsible for ensuring the efficiency, quality, and compliance of our production lines, working with complex chemical and biological processes. The ideal candidate will have a strong background in chemical engineering principles, GMP environments, and process validation. You will play a crucial role in troubleshooting production issues, implementing continuous improvement initiatives, and ensuring adherence to regulatory standards. This position demands excellent analytical skills, a problem-solving mindset, and the ability to collaborate effectively with cross-functional teams including production, quality assurance, and research & development.
Responsibilities:
Qualifications:
Responsibilities:
- Design, develop, and optimize manufacturing processes for pharmaceutical products.
- Conduct process hazard analyses (PHAs) and implement safety measures.
- Develop and execute process validation protocols (IQ, OQ, PQ).
- Troubleshoot and resolve operational issues on the production floor.
- Implement continuous improvement projects using methodologies like Lean Six Sigma.
- Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, EMA).
- Analyze production data to identify areas for efficiency and yield improvement.
- Collaborate with R&D and QC departments on new product introductions and process transfers.
- Prepare technical documentation, reports, and standard operating procedures (SOPs).
- Train production personnel on new processes and equipment.
Qualifications:
- Bachelor's or Master's degree in Chemical Engineering or a related field.
- 7+ years of experience in process engineering within the pharmaceutical or biotech industry.
- In-depth knowledge of GMP regulations and validation principles.
- Experience with process simulation and modeling software.
- Strong understanding of unit operations relevant to pharmaceutical manufacturing.
- Excellent analytical, problem-solving, and project management skills.
- Proficiency in statistical process control (SPC) and data analysis.
- Effective communication and teamwork abilities.
- Experience with scale-up from laboratory to commercial production.
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9