Sr Engineer I, Manufacturing Sciences
About The Position
About this role The Senior Engineer I, Manufacturing Sciences is a key technical contributor providing subject matter expertise across end-to-end single-use consumable raw materials, from Drug Substance through Drug Product fill. This role supports the Process Optimization & Technology (PO&T) organization by assessing raw material changes, deviations, CAPAs, and regulatory documentation, while serving as the Subject Matter Expert (SME) of extractables and leachables (E/L) program assessments. The position partners closely with suppliers, manufacturing sites, and regulatory teams to ensure materials are fit for use, compliant with evolving global regulations, and capable of supporting both current and future manufacturing needs. This is a hybrid role with on-site presence required during inspections and vendor audits.
Requirements
- Bachelor’s degree in relevant scientific or technical fields from an accredited college or university
- At minimum 4 years of directly relevant industry or industry-adjacent experience
- Proven scientific and analytical skills to evaluate suitability of plastics and single-use technologies across multiple manufacturing modalities
- Knowledge of polymeric materials, chemistry, and single-use systems for biopharmaceutical manufacturing
- Experience supporting deviations, change controls, CAPAs, and regulatory documentation
- Previous experience performing root cause analysis and risk-based technical assessments
- Willingness and ability to work on-site more frequently during training periods, critical projects, audits, etc.
Nice To Haves
- Bachelor’s degree in engineering, chemistry, materials science, or a related technical field from an accredited college or university
- Hands-on experience with extractables and leachables studies and regulatory expectations
- Familiarity with single-use systems, container closure systems, and supplier change management
- Experience supporting regulatory inspections and vendor audits
- Prior experience acting as a technical lead or SME within a manufacturing or engineering organization
- Participation in industry forums, external collaborations, or technical working groups related to E/L or single-use technologies
- Previous experience partnering with external contractors and vendors
Responsibilities
- Serve as a technical Subject Matter Expert (SME) for single-use consumable raw materials, supplier capabilities, control strategies, and manufacturing needs across the global manufacturing network
- Support development and implementation of raw material control strategies and monitoring technologies to enable incoming material release
- Lead continuous improvement initiatives related to raw materials, including technical support for new item requests and supplier audits
- Conduct investigations by performing laboratory experiments, gathering supplier data, developing historical trends, and assessing lot usage
- Troubleshoot single-use material failures (e.g., filter integrity test failures), perform root cause analyses, and evaluate potential process impacts
- Perform technical risk assessments for Vendor Change Notifications (VCNs) and New Item Requests (NIRs), including chemical compatibility, stability, thermal properties, and extractables/leachables impact
- Own and support global extractables/leachables studies, ensuring alignment with current global regulatory guidance
- Participate in industry forums and external E/L collaborations to advance best practices
- Support internal and agency inspections, vendor audits, and regulatory filings related to raw materials and single-use technologies
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
