Validation Engineer Jobs

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

MAJOR DUTIES & RESPONSIBILITIES:

• Duties may include internal compliance or efficiency improvement efforts within department.
• Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade).
• Executes technical work assignments as a point of contact for project stakeholders.
• Performs assessment of validation work and executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.
• Provides validation support, to multi-function teams, and advises operations on validation matters.
• Executes 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).
• Ensures alignment with BMS directives and industry guidelines on validation.

KNOWLEDGE and SKILLSET:

• Work both independently and in a team environment at all levels of the organization in particular Quality, Engineering and Manufacturing Operations.
• Knowledge of engineering and science generally attained through studies resulting in a B.S in engineering (Chemical preferred), a related discipline, or its equivalent.
• Project management, communication, and technical writing skills are required.
• Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
• Ability to manage one’s emotions and impulses to prevent negative impact on productivity.
• DCS and PLC based experience, preferably gained in the pharmaceutical industry.
• Work within all Site facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE).
• Knowledge of biopharmaceutical processing including a minimum of 2 years of experience developing and/or testing process automation system software (preferably Delta V batch). Experience with large scale distributed control systems desired.
• Understanding of lean principles is a plus.
• Understanding of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
• The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.

DECISION MAKING:

• Exercises sound judgment in making decisions and recommendations within generally defined practices and policies with little guidance, notifying management when necessary.
• 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.
• Typically makes recommendations to Manager but does not make final decisions.
• 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:

• Incumbents act independently (often in line with Lead Validation Engineer suggestion) to determine methods and procedures on new assignments.
• Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.
• Work is reviewed and measured based on meeting established objectives and schedules.
• Receives assignments in the form of objectives and establishes goals to meet objectives.

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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 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 [email protected]. 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.