Job Details
Sr. Specialist, 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
Responsibilities & Duties
Responsible for implementing the design, implementation and maintenance of a robust validation lifecycle for process equipment, SIP/CIP processes, critical process equipment & utility systems, process automation systems and manufacturing execution system recipes, computer systems, and laboratory instrumentation.
Implement validation philosophies and master plans required to drive the validation lifecycle of a fully automated biologics manufacturing facility.
Responsibilities include oversight 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.
Responsible to contribute in the preparation for regulatory inspection readiness.
Work collaboratively with peers within the Validation Execution function, Manufacturing Systems, Information Technology, Manufacturing, Manufacturing Engineering and Quality Effectively manage workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
Ensure alignment with BMS directives and industry guidelines on validation and quality engineering.
Execute validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs.
This individual works at the highest level and collaborates with Quality Assurance, to establish appropriate, risk-based validation methodologies. Contributes to multi-function teams, representing validation.
Qualifications
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.
A minimum of 4 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
Knowledge process equipment and system qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping is required.
Experience in designing and implementing quality systems and validation program elements required to manage the validation lifecycle of a fully automated, multi-product, biologics manufacturing facility.
Knowledge in establishing site and program validation strategies that are aligned with current industry mindsets.
Understanding of lean principles and establishment of effective process metrics is preferred.
Project management, communication, and technical writing skills are required.
Possess the professionalism and technical competency required to represent the department before our stakeholders, and management.
Understanding of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment.
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.
Understands business needs and synthesizes solutions across functions.
Demonstrated emotional intelligence required to inspire and influence the behaviors and performance of others.
The flexibility required to constructively lead and encourage peers and team members to drive results in a changing environment.
Contacts
Work both independently and in a team environment at all levels of the organization, in particular Quality, Engineering and Manufacturing Operations.
Working Conditions
Work within all Site Facilities, including laboratory settings, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE).
Decision Making
Exercises sound judgment in making decisions and recommendations within generally defined practices and policies with little guidance, notifying management when necessary.
Typically makes recommendations to Manager but does not make final decisions.
May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
Becomes actively involved as required to meet schedules or resolve problems.
Erroneous decisions or failure to achieve results may have financial implications or cause delays in schedules.
Supervision Received
Incumbent performs all standard tasks completely and independently (often in line with Sr. Validation Engineer/Manager suggestion) to determine methods and procedures on new assignments.
Receives assignments in the form of objectives and establishes goals to meet objectives.
Work is reviewed and measured based on meeting established objectives and schedules.
Only unusual or difficult tasks require supervisory review of anything other than final results.
#LI-Onsite
If you come across a role that intrigues you but doesn’t 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
COVID-19 Information
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.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.