Bristol Myers Squibb · 2 days ago
Senior Manager Validation Engineering
Devens, MA
Full-time
Onsite
Senior Level
$139K/yr - $169K/yr
6+ years expBristol Myers Squibb is a company dedicated to transforming patients' lives through science. They are seeking a Senior Manager of Validation Engineering to lead the qualification lifecycle of facility, utility, and processing equipment systems while managing multiple validation projects and ensuring compliance with industry guidelines.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility and processing equipment systems
Leads functions responsible for installation, operational and performance qualification (I/O/PQ) of systems arising from projects and change controls
Leads the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance. Ensures execution of program to predefined schedule
Establish validation project plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality
Responsibilities include oversight of validation execution work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs. This individual works in conjunction with Validation Management peers, Validation Program management and Quality Assurance to establish appropriate plans and strategies aligned with site validation philosophies
Responsible to deliver validation projects under strict deadlines to ensure customer success and bulk drug supply, this includes the establishment of plans, protocols, test scripts, risk assessments, and summary reports
Manage multiple projects while serving as a point of contact for validation execution projects
Responsible to act as a validation subject matter expert (SME), serving as the primary point of contact to present validation philosophies and strategies to Board Of Health (BOH) inspectors and auditors
Works collaboratively with Engineering, Digital Plant, Manufacturing and Quality
Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies
Ensure alignment with BMS directives and industry guidelines on validation
Develops and leads a high-performance team responsible for validation execution, manages the recruitment and development of staff, invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition
Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time
Qualification
Required
Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience
This position requires a B.S. degree in a scientific, technical or engineering discipline
A minimum of 6 years relevant experience with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in a biologics manufacturing facility
Direct experience with equipment, facility, sterilization qualification, critical utilities validation, and temperature mapping concepts is required
Excellent project management, communication, and technical writing skills are required
The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management
Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures
Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing
Proven ability working in a matrix environment and leading multi-level / cross-functional teams to achieve the highest performance in meeting site and departmental objectives
Preferred
Previous managerial experience which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources
Experience with Board of Health (BOH) Inspectors, External Auditors, Corporate and Internal Auditors presenting validation philosophies, strategies and executed testing
Familiarity with distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts
A working understanding of lean principles
Benefits
Health Coverage Medical, pharmacy, dental, and vision care.
Wellbeing Support Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection 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
US Exempt Employees flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Eligibility Disclosure The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-09
2026-01-08
2026-01-07
Company data provided by crunchbase