Position Summary | The Senior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers. |
Duties and Responsibilities
| - Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
- Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
- Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
- Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
- Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
- Identify and order materials required to perform development and manufacturing
- Identify tooling and equipment required to perform development and manufacturing
- Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
- Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
- Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
- Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
- Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
- Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
- Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
- Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
- Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
- Carry out all job responsibilities in a safe manner
- Develop equipment and processes that meet safety codes, policies and guidelines
- Provide for the safety and well-being of operators, maintenance, and other personnel
- Confer with scientists or engineers to conduct analyses of research projects, interpret test results or develop procedure and standard tests
- Other duties as assigned
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Regulatory Responsibilities | - Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable
- Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
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Supervisory Responsibilities | - Lead/support validation activities including equipment validation and process validation
- Lead problem solving and investigate quality events related to formulation process or batch records
- Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
- Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
- Supervise, mentor and develop team members or relevant personnel across departments
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Experience | - A minimum of three (3) years of experience in pharmaceutical research and manufacturing
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Education | - Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
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Knowledge, Skills & Abilities | - Experience in sterile manufacturing is preferred
- Experience in lyophilization and terminal sterilization techniques are a plus
- Knowledge of parenteral drug product manufacturing
- Proficient with calculation, data analysis, statistics and applied mathematics
- Exceptional computer skills including Microsoft Office, Visio or other related software
- Excellent writing skills
- Attention to detail
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Physical Requirements | - Ability to sit for prolonged periods of time
- Ability to stand for prolonged periods of time
- Able to lift up to 50lbs
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