Sr Validation Engineer

Bristol Myers Squibb • Indianapolis, IN

34d • Onsite

About The Position

The Senior Validation Engineer will lead validation efforts to support the Radiopharmaceutical facility and GMP operations in Indianapolis. This role is responsible for the development, execution, and management of commissioning, qualification, and validation (CQV) documents and protocols for highly specialized facility, utility, analytical, and process equipment. The Senior Validation Engineer utilizes a broad range of engineering disciplines to ensure seamless progression from construction to clinical development and commercial GMP operations. Responsibilities include onboarding advanced technologies (such as isolator-based sterile systems), guiding process development, supporting GMP operations, managing investigation and CAPA processes, driving continuous improvement initiatives, and supporting future facility expansion projects.

Requirements

• BS or MS in a scientific discipline or engineering field (advanced degrees preferred).
• Minimum 5 years of experience in radiopharmaceutical or injectable GMP manufacturing environment.
• Minimum 5 years of validation experience in GMP environments, with direct isolator technology and aseptic processing experience required.
• Advanced technical writing and documentation skills.
• Expert knowledge of regulatory guidelines for validation, risk management, and isolator-based processes.
• Proven leadership capabilities, independent mindset, and effective problem-solving abilities.
• Highly organized professional with exceptional communication, interpersonal, and mentoring skills.
• Track record of leading teams and cross-functional projects in GMP environments.
• Strong multi-disciplinary engineering background, with specific expertise in isolator systems for sterile manufacturing.
• High professional ethics, integrity, and ability to maintain confidential information.

Responsibilities

• Serve as validation subject matter expert for the commissioning and qualification of a 60,000 sq. ft. office, warehouse, and GMP Radiopharmaceutical production facility, including isolator-based aseptic processes.
• Lead the strategy and implementation of CQV programs for GMP spaces: office, warehouse, development, quality control, sterility/microbiology, and GMP production, with emphasis on isolator and containment technologies.
• Direct and coordinate consultant(s) and project teams in the execution of validation activities and continuous improvement initiatives.
• Partner cross-functionally with Engineering, QC, and Operations to develop and implement new processes and onboarding of new technologies, including advanced isolator systems.
• Provide senior-level validation oversight and support for ongoing development and GMP manufacturing operations.
• Guide, mentor, and cross-train team members to broaden validation capabilities, including process validation, cleaning validation, CSV, and QC asset validation.
• Own and drive key validation areas and projects, establishing and maintaining best practices for isolator technology and sterile operations.
• Lead complex deviation investigations, data reviews, CAPA management, change controls, and ensure robust technical documentation.
• Author, review, and approve GMP documentation including SOPs, forms, protocols, technical documents, reports, deviations, CAPA, and change controls.
• Support and represent the validation function during Health Authority inspections and audits.
• Monitor and report on department KPIs to drive performance improvement.
• Execute and provide technical support for equipment and process validation, including hands-on experience with isolator-based sterile filling and process systems.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees