Senior Specialist, Validation Engineer II
Bristol Myers Squibb
6 months ago
On-site
Devens, MA
Operations
Principal Objective of the Position
- The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing and laboratory equipment alongside facilities and utilities at multi-use sites by qualifying and maintaining equipment systems in a qualified/validated state according to established policies and procedures.
Major Duties and Responsibilities
- Develop and execute validation/qualification deliverables (Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports).
- Ensure periodic reviews and requalification are performed per schedule.
- Support equipment qualification and validation activities.
- Develop qualification protocols and associated reports while adhering to change management.
- Author and review SOPs, WPs, test protocols, and validation deliverables/plans/policies as needed.
- Perform validation lifecycle maintenance (validation document hierarchy, tracking execution work from change controls, shutdown/changeover validation management, and management of revalidation and cleaning monitoring programs if necessary).
- Execute work from change strategy, risk assessment, testing, and compliance gaps.
- Execute a portfolio of limited-scope and complex validation projects under strict deadlines.
- Maintain familiarity with qualification/validation directives and industry guidelines.
Customer Service / Support
- Review, prioritize, and promptly respond to end-user equipment qualification and support requests.
- Provide technical support and guidance; interface with customers to meet expectations.
- Maintain positive relationships and contribute to multi-function teams representing validation.
Regulatory Responsibilities
- Align with validation and quality engineering directives/guidelines.
- Serve as SME in internal and regulatory audits as needed.
- Contribute to regulatory inspection readiness.
- Perform other duties as assigned.
Knowledge and Skill (Required/Preferred)
- Familiarity with cGMP in the pharmaceutical industry.
- Preferred: direct experience with equipment, facility, sterilization commissioning/qualification, critical utilities validation, temperature mapping.
- Suggested: distributed control systems and automation (GAMP) validation concepts.
- Knowledge required to design/implement quality systems and validation program elements for automated multi-product biologics/cell therapy manufacturing.
- Familiarity with regulatory validation requirements (FDA, EMA, ICH Q7/Q8/Q9) particularly for biologics/cell therapy.
- Preferred: lean principles and six sigma.
- Proficiency in project management, communication, and technical writing.
- Ability to handle multiple priorities, solve complex/unusual problems, and work independently.
- Working knowledge of SOPs, cGMPs, compliance requirements, and regulatory guidelines (FDA/EU); demonstrated via previous site-level validation philosophy/regulation projects.
- Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical industry.
Qualifications
- Required: BS in Chemical Engineering, Mechanical Engineering, related discipline (or equivalent).
- Required: 3+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation), and lab instrumentation in an FDA-regulated manufacturing facility.
- Required: 2+ years’ experience in equipment, facility, or utility qualification.
Benefits (explicitly included)
- Compensation range (Devens, MA): US $92,540–$112,136 (additional incentive cash/stock may be available).
- Health Coverage (medical, pharmacy, dental, vision), wellbeing programs, and financial protection (401(k), disability, life insurance, etc.).
- Paid Time Off (including flexible time off/paid holidays; additional eligibility-based time off such as paid sick time, volunteer days, summer hours, leaves of absence, and annual Global Shutdown).
Application Instructions
- If applying despite not perfectly matching, candidates are encouraged to apply anyway.
- The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing and laboratory equipment alongside facilities and utilities at multi-use sites by qualifying and maintaining equipment systems in a qualified/validated state according to established policies and procedures.
Major Duties and Responsibilities
- Develop and execute validation/qualification deliverables (Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports).
- Ensure periodic reviews and requalification are performed per schedule.
- Support equipment qualification and validation activities.
- Develop qualification protocols and associated reports while adhering to change management.
- Author and review SOPs, WPs, test protocols, and validation deliverables/plans/policies as needed.
- Perform validation lifecycle maintenance (validation document hierarchy, tracking execution work from change controls, shutdown/changeover validation management, and management of revalidation and cleaning monitoring programs if necessary).
- Execute work from change strategy, risk assessment, testing, and compliance gaps.
- Execute a portfolio of limited-scope and complex validation projects under strict deadlines.
- Maintain familiarity with qualification/validation directives and industry guidelines.
Customer Service / Support
- Review, prioritize, and promptly respond to end-user equipment qualification and support requests.
- Provide technical support and guidance; interface with customers to meet expectations.
- Maintain positive relationships and contribute to multi-function teams representing validation.
Regulatory Responsibilities
- Align with validation and quality engineering directives/guidelines.
- Serve as SME in internal and regulatory audits as needed.
- Contribute to regulatory inspection readiness.
- Perform other duties as assigned.
Knowledge and Skill (Required/Preferred)
- Familiarity with cGMP in the pharmaceutical industry.
- Preferred: direct experience with equipment, facility, sterilization commissioning/qualification, critical utilities validation, temperature mapping.
- Suggested: distributed control systems and automation (GAMP) validation concepts.
- Knowledge required to design/implement quality systems and validation program elements for automated multi-product biologics/cell therapy manufacturing.
- Familiarity with regulatory validation requirements (FDA, EMA, ICH Q7/Q8/Q9) particularly for biologics/cell therapy.
- Preferred: lean principles and six sigma.
- Proficiency in project management, communication, and technical writing.
- Ability to handle multiple priorities, solve complex/unusual problems, and work independently.
- Working knowledge of SOPs, cGMPs, compliance requirements, and regulatory guidelines (FDA/EU); demonstrated via previous site-level validation philosophy/regulation projects.
- Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical industry.
Qualifications
- Required: BS in Chemical Engineering, Mechanical Engineering, related discipline (or equivalent).
- Required: 3+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation), and lab instrumentation in an FDA-regulated manufacturing facility.
- Required: 2+ years’ experience in equipment, facility, or utility qualification.
Benefits (explicitly included)
- Compensation range (Devens, MA): US $92,540–$112,136 (additional incentive cash/stock may be available).
- Health Coverage (medical, pharmacy, dental, vision), wellbeing programs, and financial protection (401(k), disability, life insurance, etc.).
- Paid Time Off (including flexible time off/paid holidays; additional eligibility-based time off such as paid sick time, volunteer days, summer hours, leaves of absence, and annual Global Shutdown).
Application Instructions
- If applying despite not perfectly matching, candidates are encouraged to apply anyway.