Process Development Engineer

Hologic • San Diego, CA

141d • $78,300 - $122,400

About The Position

This Process Development Engineer role in the Operations - Process Transfer group requires technical expertise in developing and troubleshooting manufacturing process in NPD and Sustaining, for oligonucleotides, Master Cell Banks, plasmids, transcripts, sub-assemblies, protein, final formulations and/or lyophilized finish product. In this role, you will lead the development, validation, transfer and implementation of new manufacturing processes; plan and execute experiments to develop process parameters and/or bring resolution to investigations resulting from non-conformances; and participate in new product development, scale-up and optimization projects and core teams. This is a fully onsite role based out of San Diego, CA.

Requirements

• Minimum of a Bachelor's Degree, preferably in Chemical Engineering, Biomedical Engineering, or relevant fields.
• Minimum of 5 years of diagnostic product/process development/transfer experience in a regulated environment (Medical Device or Pharmaceutical).

Nice To Haves

• Certification in CQE / Six Sigma Green Belt highly preferred.
• Working knowledge of QSR/QMS application.

Responsibilities

• Serve as subject matter expert (SME) in oligonucleotides, Master Cell Banks, plasmids, transcripts, sub-assemblies, protein, final formulations and/or lyophilized finish product GMP manufacturing.
• Troubleshoot complex manufacturing process problems.
• Define, monitor and analyze process parameters and data (KPIs and CQAs).
• Ensure availability of equipment/instrumentation for GMP use.
• Research, evaluate and purchase new raw material, instruments and equipment.
• Utilize root cause analysis to resolve non-conformances.
• Independently generate experiments to obtain root cause.
• Independently generate notebook studies, development reports, technical reports, development documents and manufacturing documents.
• Plan and execute CAPAs that result from non-conformance investigations.
• Develop, improve, validate and implement GMP manufacturing processes.
• Train personnel in new manufacturing processes.
• Participate in the transfer of GMP processes to and from other manufacturing sites.
• Serve as SME oversight for outsourcing manufacturing.
• Represent department as Core Team or Extended Core Team member as part of New Product Introductions.

Benefits

• Comprehensive training when you join as well as continued development and training throughout your career.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees