Manager, Validation Engineer, Cell Therapy

Bristol-Myers Squibb; Devens (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Manager, Validation Engineer to lead critical validation activities in cell therapy. This role involves developing validation strategies and ensuring compliance with FDA regulations while fostering a collaborative team environment. You will have the opportunity to innovate and streamline processes that directly impact patient care. Join a mission-driven organization that values your contributions and supports your professional growth. If you are passionate about making a difference in the lives of patients and thrive in a dynamic setting, this position is for you.

Benefits

Flexible Work Environment

Competitive Benefits

Professional Development Opportunities

Health and Wellness Programs

Qualifications

• 5+ years experience in FDA-regulated industry.
• Strong understanding of cGXP and documentation practices.
• Knowledge of pharmaceutical lab and manufacturing systems.

Responsibilities

• Supports equipment qualification and validation activities.
• Manages projects of varying scope and complexity.
• Delivers training on procedures and best practices.

Skills

Technical Writing

Project Management

cGXP Requirements

FDA Regulations

Validation Strategies

Problem Solving

Communication Skills

Organizational Skills

Education

B.S. in Engineering

Equivalent Industry Experience

Tools

Microsoft Office Suite

Client/Server Technologies

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us.

Position: Manager, Validation Engineer, Cell Therapy

Location: Devens, MA

Key Responsibilities

1. Supports equipment qualification and validation activities by providing technical impact assessments and developing sound validation strategies.
2. Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
3. Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
4. Applies strong technical skillset to investigate and resolve complex challenges.
5. Investigates and resolves Validation Deviations, CAPA investigations, and other potential issues.
6. Works with Automation/IT partners to ensure configuration and documentation of computerized systems to meet CFR21 Part 11 requirements.
7. Supervises vendors for qualification functions.
8. Completes all qualification and validation documentation with accuracy, completeness, and compliance with BMS standards.
9. Responsible for the delivery of all lifecycle deliverables in the qualification of facilities, utilities, and equipment.
10. Initiates, manages, and leads projects of moderate scope and complexity within their functional area.
11. Provides direction and leadership to team members to ensure objectives are met.
12. Manages projects of varying scope and complexity.
13. Maintains positive relationships with team members and site customers, promoting a positive learning and team environment.
14. Authors quality procedures and training documents.
15. Delivers training on procedures and best practices to departmental personnel and business partners.
16. Innovates, researches, and develops tools and solutions for departmental efficiency and compliance.
17. Supports laboratory and manufacturing equipment implementation projects, including scheduling, procurement, site prep, installation, qualification, and turnover.
18. Supports standardization efforts in review and approval of Validation Deliverables.
19. Reviews, prioritizes, and responds to qualification, validation, and support requests.
20. Provides technical support and guidance on Validation, Quality Process, and equipment qualification issues, interfacing with customers.
21. Acts as departmental delegate and SME in internal and regulatory audits.

Qualifications & Experience

1. Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S. in engineering or related discipline, or equivalent industry experience.
2. Minimum 5 years of experience in FDA-regulated industry.
3. Strong understanding of cGXP requirements and good documentation practices.
4. Strong knowledge of ISPE C&Q guidance and 21 CFR Part 11 compliance.
5. Technical writing experience with SOPs and validation documents.
6. Knowledge of MS Windows client/server technologies preferred.
7. Ability to learn new technologies and configure computerized systems to meet requirements.
8. Familiarity with SDLC, CSV, distributed control systems, and automation validation concepts.
9. Ability to identify and document User and Functional Requirements.
10. Knowledge of pharmaceutical lab and manufacturing systems.
11. Experience authoring and executing C&Q deliverables.
12. Effective interaction with manufacturing, automation/IT, laboratory, QA, and Facilities groups.
13. Strong organizational skills in high-paced environments.
14. Excellent written and verbal communication skills, including technical writing and reporting.
15. Proficiency in Microsoft Office Suite and ability to learn new software.
16. Understanding of engineering documentation such as P&IDs, Process Flow diagrams, and SOPs.

This job description does not state or imply that these are the only duties and responsibilities. Employees may be required to perform other duties as assigned by management.

If you find a role intriguing but not a perfect match, we encourage you to apply. You could be one step away from work that transforms your life and career.

Uniquely Interesting Work, Life-changing Careers

With a vision of transforming patients' lives through science, every BMS employee plays an integral role in work that goes beyond ordinary. We empower our staff to apply their talents and perspectives in a supportive culture, promoting global participation in clinical trials, guided by our values of passion, innovation, urgency, accountability, inclusion, and integrity.

On-site Protocol

BMS has an occupancy structure based on the role's responsibilities, including site-essential, site-by-design, field-based, and remote roles. Onsite presence requirements vary accordingly, with site-essential roles requiring 100% onsite work, and others possibly offering hybrid or remote options. We support accessibility and accommodations for applicants with disabilities and promote Covid-19 vaccination for staff wellbeing.

For additional information on employment policies or accommodations, contact [e-mail] or visit careers.bms.com/eeo-accessibility.