Manufacturing Process Specialist
2 weeks ago
As a key member of the Manufacturing Sciences and Technology (MS&T) team, the Process Engineer will play a vital role in facilitating the transition of innovative processes into manufacturing environments for both internal and external projects.
Key Responsibilities:
- Collaborate across various departments including Process Development, Quality Assurance, and Project Management to ensure seamless process transfer and maintenance.
- Work closely with manufacturing teams to create and manage essential batch documentation while providing technical guidance related to GMP operations.
- Lead the collection and analysis of process data, effectively communicating project updates and identifying trends.
- Assess current processes to pinpoint areas for enhancement, driving efficiency and market competitiveness.
- Draft and review critical documents such as production records, technical transfer reports, and engineering specifications.
- Serve as the primary technical resource for risk assessments, gap analyses, and corrective actions, ensuring thorough root-cause analysis and resolution strategies.
- Perform additional duties as required to support operational excellence.
Candidate Qualifications:
The ideal candidate will possess:
- A Master's degree in engineering, biotechnology, or a related discipline with up to 2 years of experience in biopharmaceutical process development or manufacturing.
- A Bachelor's degree in engineering, biotechnology, or a related field with 3 to 6 years of relevant experience.
- An Associate degree in a related area with 6 to 9 years of experience in biopharmaceutical processes.
- Experience in Upstream and Downstream processes, including mammalian cell culture and chromatography, as well as familiarity with molecular therapeutics.
- Proficiency in the design and troubleshooting of single-use consumables and manufacturing equipment.
- Strong technical acumen and hands-on experience in biological manufacturing within a GMP framework.
Why Consider Catalent:
At Catalent, we offer a structured career path, competitive compensation, and a diverse, inclusive workplace culture. Our employees enjoy:
- Comprehensive benefits from day one, including medical, dental, and vision coverage.
- Generous paid time off and holiday allowances.
- 401K matching and tuition reimbursement programs.
- Opportunities for professional growth within a global leader in drug development and delivery.
Catalent is dedicated to enhancing lives through innovation and excellence in the biopharmaceutical industry.
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