Process Engineer III, Manufacturing Sciences

This is a fully remote position, open to applicants in Missouri.

📋 Description

• Contribute technological expertise in the creation, validation, and transfer of manufacturing processes.

• Assist the Process Engineering team as the technical lead for customer programs within a manufacturing setting.

• Work collaboratively with supervisors and technicians in Operations, Quality Assurance, other Engineers, and scientists in Process Development, as well as engage with clients as the Process Engineer program leader.

• Prepare, review, and approve Standard Operating Procedures and Job Aids, consulting internally to ensure procedures are scientifically sound and robust.

• Collaborate with process development to establish standardized methodologies and explore new techniques for executing unit operations at a manufacturing scale, including cell culture, harvest, and purification.

• Contribute to Internal and Customer meetings based on reliable evidence with minimal oversight.

• Manage internal projects and tasks, lead client projects, and oversee timelines with limited supervisory support.

• Proactively identify opportunities for error-proofing and initiate engineering initiatives aimed at enhancing practices and procedures with minimal supervision.

• Offer scientific expertise for GMP deviations by evaluating, reviewing, and approving the effects of significant deviations on product quality and process validation.

• Drive changes in equipment and process design independently and proactively.

• Prepare, review, and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bills of Materials, ensuring technical accuracy and manufacturability.

• Draft, review, and approve process control documents, campaign summary reports, and process validation reports.

• Review, analyze, and trend process data independently.

• Provide technical feedback on documents generated by other departments, such as Tech Transfer Protocols and SOPs.

• Address technical issues on the manufacturing floor as needed for a 24/7 operation.

• Assist our MSAT team with additional tasks to enhance site performance, ensure patient safety, and meet customer needs.

• Facilitate development and training for Process Engineers/Scientists.

⛳️ Requirements

• A Bachelor’s degree in a scientific discipline is required, ideally in engineering.

• At least 5 years of experience in the GMP-regulated Biologics/Pharma Industry, or equivalent experience (or a master's degree in a scientific field paired with 3 years of experience, or a Ph.D.).

• Compliance with Environmental, Health, and Safety policies and procedures to maintain a safe and healthy workplace.

• Strong self-motivation and ability to prioritize work and time effectively.

• Demonstrates a solid understanding of general scientific practices, principles, and concepts.

• Capable of effective writing and communication.

• Ability to work both autonomously and collaboratively within a team.

• Familiarity with current Good Manufacturing Practices and US/EU regulations.

• Intermediate knowledge of statistical methods used for Pharmaceutical Process Analysis is advantageous.

• Proficient in Microsoft Word and Excel.

• Ability to stand for extended periods and gown into manufacturing areas.

🏝️ Benefits

• Commitment to all Good Manufacturing Practices (GMP).

• Adherence to Safety Standards.

• Provision of Personal Protective Equipment (PPE) as needed (safety glasses, gowns, gloves, lab coats, ear plugs, etc.).