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Specialist, Validation Engineer

3 months ago

Devens, Massachusetts, United States Bristol-Myers Squibb Full time

**Working with Us**

Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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: .

The Specialist, Validation Engineer I supports the successful implementation of manufacturing, and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. The incumbent is tasked with qualifying new equipment, facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

**Key Responsibilities:**

**1. 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.

+ 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.

+ Execute work arising from change strategy, risk assessment, testing and compliance gaps.

+ Executes portfolio of limited scope validation projects under strict deadlines to ensure stakeholder success and bulk drug supply. Maintains familiarity on BMS directives and industry guidelines on qualification/validation.

**2. Promotes and provides excellent customer service and support:**

+ Regularly reviews, prioritizes, and promptly responds to end user equipment qualification and support requests.

+ Provides technical support and guidance on qualification and validations issues.

+ Interfaces 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.

+ Contributes to multi-function teams, representing validation.

**3.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.

**Knowledge and Skill:**

+ You should have executed smaller technical projects. You must have 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.

+ A working understanding of lean principles and six sigma process is preferred.

+ 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.

**Qualifications:**

+ 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.

+ (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.

**#LI-ONSITE #BMSBLDMA**

_If you come across a role that intrigues you but doesnt perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career._

**Uniquely Interesting Work, Life-changing Careers**

With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

**On-site Protocol**

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit ) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

**Company:** Bristol-Myers Squibb

**Req Number:** R

**Updated:** :54:48.557 UTC

**Location:** Devens-MA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.