Validation Engineer, Sterility & CQV

Bristol Myers Squibb•Indianapolis, IN

5d•$96,148 - $116,508•Onsite

About The Position

The Validation Engineer II, CQV Sterility Assurance supports the radiopharmaceutical facility and GMP operations in Indianapolis by drafting, executing, and maintaining commissioning, qualification, and validation documentation for facility, utility, analytical, laboratory, sterility assurance, and process systems. This role supports validation lifecycle activities for aseptic manufacturing environments, environmental monitoring programs, analytical laboratory instrumentation, cleanroom performance qualification, and GMP study execution. The position partners with Quality, Manufacturing, Engineering, QC, Operations, consultants, contractors, and project teams to ensure systems, equipment, and processes are qualified, maintained in a validated state, and aligned with applicable regulatory requirements, company procedures, and contamination control expectations.

Requirements

BS or MS in scientific related field or equivalent work experience
2-5 years of experience in Radiopharmaceutical, injectable, sterile manufacturing, aseptic processing, analytical laboratory, quality control, or GMP manufacturing environment
2-5 years of validation experience within a GMP environment
Good technical writing skill-set
Solid understanding of regulatory guidelines for validation, lifecycle management, data integrity, documentation practices, and risk management
Working knowledge of GMP requirements, CQV principles, sterility assurance, contamination control, environmental monitoring, analytical laboratory instrumentation, and risk-based validation methodologies
Must possess an independent mindset, tenacity, sound judgment, and attention to detail
Highly motivated and organized professional with strong interpersonal, communication, problem-solving, data analysis, and planning skills.
Proven experience working with teams in a GMP environment.
Multi-disciplined engineer with GMP experience
Excellent professional ethics, integrity, and ability to maintain confidential information.
Uses AI tools to enhance individual productivity and quality of work

Nice To Haves

Experience drafting, executing, or reviewing qualification and validation protocols is preferred

Responsibilities

Work with the project team, General Contractor, consultants, and cross-functional partners as required to support commissioning, qualification, and validation activities for GMP and supporting spaces, including office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
Develop, implement, execute, and maintain CQV strategies for facility, utility, analytical, laboratory, sterility assurance, and process systems.
Support environmental monitoring programs, aseptic process simulations/media fills, airflow visualization smoke studies, cleanroom performance qualification, disinfection and sanitization validation, and VHP/bio-decontamination studies.
Execute qualification activities for laboratory and analytical equipment, including HPLC/UPLC systems, gas chromatographs, UV-visible spectrophotometers, TOC analyzers, particle counters, endotoxin testing instruments, and microbiology laboratory equipment.
Provide validation support for day-to-day development, GMP manufacturing, laboratory, and operational activities, including troubleshooting, data review, investigation support, and validation impact assessments.
Expand expertise in additional areas of validation, including process validation, QC assets, cleaning validation, sterility assurance, and analytical equipment qualification.
Own and manage assigned validation areas or project workstreams while supporting validated state maintenance.
Apply technical knowledge and abilities to investigate manufacturing, laboratory, sterility assurance, and validation-related deviations.
Review data and documentation to support investigations, deviation closure, CAPA effectiveness, change control implementation, inspection readiness, and validated state maintenance.
Draft GMP documentation including but not limited to SOPs, forms, protocols, technical documents, reports, deviations, CAPAs, change controls, test scripts, and summary reports.
Support Health Authority inspections, internal audits, and department KPI tracking related to validation performance, execution status, and compliance.
Mentor and cross-train other team members.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
11 paid national holidays
Unlimited paid sick time
up to 2 paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
an annual Global Shutdown between Christmas and New Years Day.