Senior Engineer I, Manufacturing Sciences and Technology

Here's What You'll Do

• Support and improve business processes for introducing new consumables and raw materials, providing the technical expertise and guidance needed to establish robust unit operations and long-term material strategies.
• Contribute to consumable design and support scale-up and technology transfer activities, connecting material requirements with manufacturing process needs.
• Troubleshoot process and equipment issues and lead the resolution of internal and supplier deviations.
• Drive investigations through the identification and implementation of corrective and preventive actions (CAPAs), bringing technical rigor to problem-solving across materials, equipment, and unit operations.
• Lead impact assessments of supplier change notifications and serve as a technical representative in supplier relationships, collaborations, and troubleshooting, coordinating with internal stakeholders to evaluate implications for materials and manufacturing processes.
• Serve as the lead writer for BLA and MMA submissions, including the preparation of clinical and non-clinical overviews and summaries, clinical study reports (CSRs), and other key modules in the Common Technical Document (CTD) format.
• Follow all relevant regulations, guidelines, and company policies to ensure compliance with internal Regulatory, Environmental, Health and Safety (EHS), and current Good Manufacturing Practice (cGMP) requirements.
• Partner with Technical Development, Supply Chain, Procurement, Quality, and Regulatory Affairs to drive a critical materials improvement roadmap encompassing supply chain integration, cost savings and avoidance, and consumables library simplification.
• Ensure global alignment of testing strategies that meet or exceed regulatory requirements.
• Ensure Extractables and Leachables (E&L) strategies and guidance documents are aligned across sites, kept current, and meet all current regulatory requirements.
• Work with sites to support site-level ownership of E&L studies and risk assessments.
• Execute tasks precisely as defined in internal guiding documents, including, but not limited to, standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements, ensuring that data, documentation, and records are completed and maintained for business use and remain available to support audits and inspections.
• Complete training in your assigned required learning plan within the defined timelines and according to the prescribed requalification cadence.
• Explore opportunities to apply Generative AI tools, where approved, to technical knowledge synthesis and documentation support, maintaining human oversight and compliance with company policies and Data Integrity requirements.

Here's What You'll Need (Basic Qualifications)

• Education: BS/MS in mechanical engineering, material science, or related technical discipline
• Experience: Minimum of 5 years of industry experience in process development, manufacturing, engineering, or similar technical role. 8-12 years preferred.
• Demonstrated aptitude or ability to learn to gain a strong understanding of GxP and GMP regulations.