Sr. Validation Engineer

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 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: careers.bms.com/working-with-us

Principle Objective of Position

• Qualify the configuration of the Process Control System (DeltaV) and Manufacturing Execution System (MES), which support clinical and commercial manufacturing facilities.  Manage protocol generation, test execution, issue resolution and approval of qualification efforts to assure readiness for intended use to meet policy and compliance requirements.

Major Responsibilities & Duties

• Leads the validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System) in a highly automated biologics manufacturing facility.

• Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Process Automation System (Delta V).

• Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade).

• Executes and/or leads validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs

• Develops appropriate validation methodologies in collaboration with Operations management and Quality Assurance for novel projects.

• Leads a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.

• Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.

• Provides validation subject matter expertise (SME), to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies.

• Ensures alignment with BMS directives and industry guidelines on validation.

• Duties may include internal compliance or efficiency improvement efforts within department.

Knowledge & Skill

• Specific technical skills with biopharmaceutical processing including a minimum of 6 years of experience developing and/or testing process automation system software (preferably Delta V batch).  Understanding of S88 and batch processing operations required.  Practical experience with large scale distributed control systems required.

• Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent. 

• Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.

• Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.

• Comprehensive DCS and PLC based experience, preferably gained in the pharmaceutical industry.

• Knowledge of procedural batch processing automation in a Delta V environment.

• Knowledge of a system life cycle validation techniques for automation software specification and development.

• Familiar with construction techniques and automation system hardware installation practices.

• Experience with dealing with recognized large automation providers (Emerson, Rockwell preferred).

• 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 is a suggested.

• Demonstrated proficiency in project management, oral communication, and technical writing skills are required.

• The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.

#LI-Onsite

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

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