Sr Engineer I, Manufacturing Sciences

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. What you’ll do 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 Who you are You are a technically curious and analytical engineer who enjoys solving complex manufacturing challenges and collaborating across functions. You work independently, proactively identify improvements, and are comfortable serving as a technical leader within your area of expertise.

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.

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   Job Level: Professional Additional Information The base compensation range for this role is: $98,000.00-$127,000.00