Sr Engineer, Process

• ◆Provide direct, real-time process engineering support on the manufacturing floor for GMP vaccine drug substance operations, including upstream, downstream, and process support systems.
• ◆Lead and execute troubleshooting of process and equipment deviations, collaborating with cross-functional teams to identify root causes and implement effective CAPAs.
• ◆Serve as process owner and subject matter expert (SME) for assigned unit operations and manufacturing systems, ensuring robust and compliant operation.
• ◆Support and lead process improvements, optimization initiatives, and capacity enhancements using data-driven and risk-based approaches.
• ◆Author, review, and approve GMP documentation including deviations, change controls, process risk assessments, protocols, reports, and regulatory-facing technical documentation.
• ◆Support technology transfer activities, including process characterization, equipment fit assessments, and operational readiness for new or modified processes.
• ◆Lead or execute commissioning, qualification, and validation activities for process equipment and systems, including support of FATs, SATs, and PPQ.
• ◆Partner with Quality Assurance to ensure alignment with Quality Systems, data integrity requirements, and regulatory commitments.
• ◆Provide technical input during regulatory inspections and audits and present process and equipment information as a subject matter expert.
• ◆Collaborate with vendors, contractors, and internal engineering groups to support equipment reliability, lifecycle management, and continuous improvement.
• ◆Mentor junior engineers and contribute to engineering standards, best practices, and knowledge sharing across the site.

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company’s vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

• ✓Bachelor’s degree in Chemical, Biochemical, Mechanical, or related Engineering discipline; advanced degree preferred.
• ✓Minimum of 7–10 years of progressive process engineering experience in GMP-regulated biopharmaceutical or vaccine drug substance manufacturing.
• ✓Demonstrated hands-on experience supporting manufacturing operations, including real-time troubleshooting and floor support in a GMP environment.
• ✓Strong working knowledge of vaccine or biologics unit operations, including upstream processing, downstream purification, formulation, CIP/SIP, and single-use technologies.
• ✓In-depth understanding of GMP regulations, validation lifecycle, change management, deviation management, and data integrity princip