Specialist Manufacturing 35421
On-site · Juncos, Juncos, Puerto Rico
Job Summary
Specialist Manufacturing role supporting GMP manufacturing operations across bioprocessing units; responsible for change controls for manufacturing process changes, deviation investigations, CAPA activities, process validation support, generation of training materials, and providing technical guidance. Collaborates with cross-functional teams, prepares and presents technical reports, conducts root cause analyses, participates in risk assessments, contributes to campaign readiness, and assists with Master Batch Record creation/revisions while ensuring procedures reflect current operations and regulatory expectations.
Required Qualifications
- Educational background in Life Sciences and/or Engineering
- Experience in handling deviations/non-conformances investigations
- Skills for technical writing and development of reports
- Knowledge and experience with root cause analysis tools (e.g. causal factors analysis, 5 Why’s)
- Project management skills on identifying/tracking actions and achieving due dates
- Detailed technical understanding of bioprocessing unit operations
- Skilled in performance of GMP production operations
- Regulatory knowledge and interactions
- Participate and help lead cross-functional teams
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
- Organizational, technical writing and presentation skills
- Basic project management skills
- Basic knowledge of control charting
- Education: Doctorate OR Master’s + 2 years of Manufacturing Operations experience OR Bachelors + 4 years of Manufacturing Operations experience OR Associates + 8 years of Manufacturing Operations experience OR High school/GED + 10 years of Manufacturing Operations experience
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.