Job Title: Senior Automation Engineer
Department: MSAT Manufacturing (MFG)
Contract Duration: 12 months
Position Overview:
Our client is seeking an experienced Senior Automation Engineer to join our MSAT Manufacturing team. This role involves managing and optimizing complex biopharmaceutical processes, ensuring seamless production, and providing expertise for process transfer projects. The ideal candidate will be an innovative problem-solver who excels in a collaborative, cross-functional environment to drive process improvements within a GMP-regulated facility.
Key Responsibilities:
- Process Transfers and Implementation: Lead and manage the transfer and integration of new manufacturing processes within our GMP facility, supporting both internal and external client projects.
- Technical Expertise and Support: Act as a primary technical resource, providing scientific and technological guidance during process transfers, launches, and initial product supply.
- Strategic Leadership and Mentorship: Offer strategic direction, technical leadership, and mentorship to junior team members. Tackle troubleshooting, process improvements, and tech transfers for bio-pharmaceutical operations.
- Process Management: Serve as the technical lead for upstream and downstream manufacturing, including activities like cell culture preparation, bioreactor operations, filtration, chromatography, and product formulation.
- Continuous Improvement: Identify and implement at-scale manufacturing innovations to enhance GMP operations, quality, and efficiency.
- Cross-Functional Collaboration: Work alongside cross-functional teams and external clients, conducting facility-fit assessments, project planning, and materials management for mid- to high-complexity projects.
- Documentation and Reporting: Author and maintain comprehensive technical documentation, including Process Descriptions, Engineering Test Protocols, and technical sections for regulatory filings.
- Data Analysis and Reporting: Design, develop, and utilize data repositories for process monitoring and trend analysis to improve large-scale production.
Required Skills & Experience:
- Proven experience in biopharmaceutical manufacturing processes, with a strong foundation in both upstream and downstream operations.
- Hands-on expertise in aseptic processing, mixing, buffer preparation, and in-process analytics for large-scale GMP manufacturing.
- Strong technical writing and regulatory filing experience (e.g., BLA, CMC dossiers).
- Solid project management skills and experience working effectively in high-pressure, cross-functional settings.
- Proficiency with engineering and mathematical principles related to cell culture, fluid/gas transfer, and mixing.
- Excellent mechanical aptitude and problem-solving skills.
- Advanced competency in Microsoft Office and the ability to design and develop data visualizations.
- Strong communication skills, with the ability to work both independently and as part of a team.
Physical Requirements:
- Ability to gown into GMP areas.
- Capability to stand for extended periods and lift up to 50 lbs. with assistance.
- Willingness to support a 24/7 production environment as needed.
Education:
- Bachelor’s Degree in Biochemical Engineering or a related field with 6+ years of experience in biopharmaceutical manufacturing, OR
- Equivalent of 10+ years of technical experience in large-scale manufacturing environments.
If you're a proactive, innovative professional eager to bring your skills to a dynamic biopharmaceutical manufacturing environment, we invite you to apply and join the team!
