Bristol Myers Squibb · 5 hours ago
Specialist, Validation Engineer l
Devens - MA - US
Full-time
Onsite
Entry Level
$87K/yr - $105K/yr
1+ years expBristol Myers Squibb is a company that transforms the lives of patients through meaningful work. The Specialist, Validation Engineer I supports the implementation and maintenance of manufacturing and laboratory equipment, ensuring they remain in a qualified state and comply with established policies. The role involves developing validation plans, executing qualification protocols, and providing technical support to internal customers.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Maintains qualified equipment systems in compliance with policies, guidelines and procedures:
Develops and executes validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports
Ensure periodic reviews and requalification is being performed in accordance with schedule
Supports equipment qualification and validation activities. Develops qualification protocols, and associated reports while adhering to a change management process
Author Development/Review of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed
Responsibilities include execution of validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from change controls, shutdown/changeover management related to validation, and management of the revalidation and cleaning monitoring programs, if necessary
Promote and provide excellent customer service and support
Regularly review, prioritize, and promptly respond to end user equipment qualification and support requests
Provide technical support and guidance on qualification and validations issues
Interface with customers to ensure all expectations are being met
Maintain a positive relationship with all team members and site customers while promoting a positive team environment
Contribute to multi-function teams, representing validation
Regulatory Responsibilities
Ensure alignment with BMS directives and industry guidelines on validation and quality engineering
Responsible to contribute to the preparation for regulatory inspection readiness
Performs other duties as assigned
Qualification
Required
Knowledge of engineering generally attained through studies resulting in a Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required
Executed smaller technical projects. Demonstrated effectiveness working in both a team environment as well as an individual contributor role
Familiarity of cGMP in the pharmaceutical industry
Familiarity of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics / cell therapy manufacturing
Demonstrated ability in project management, communication, and technical writing skills suggested
Experienced self-motivated individual who can handle multiple priorities to meet project team goals and timelines
Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the general understanding to work within a regulatory environment. Knowledge must be demonstrated through previous projects of establishing validation philosophies and regulations at a site level
Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
Strong level of problem-solving skills, verbal and written communication skills, and the ability to work independently
Preferred
A minimum of 1+ years relevant experience (co-op or internship experience) with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility
A working understanding of lean principles and six sigma process is preferred
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
Based on eligibility*, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day.
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
2026-01-25
The Motley Fool
2026-01-24
Company data provided by crunchbase