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SUMMARY:

We are seeking a highly skilled and motivated Computer System Validation (CSV) Engineer to join our team at Devens Cell Therapy Facility. The CSV Engineer will be responsible for ensuring that all computer systems and software used in our manufacturing and laboratory environments comply with regulatory requirements and industry standards. This role involves the development, execution, and maintenance of validation protocols and documentation to support the validation lifecycle of GxP systems.

Key Responsibilities:

• Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for computer systems and software applications used in GxP environments.
• Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GAMP 5, 21 CFR Part 11, etc.).
• Collaborate with cross-functional teams, including IT, Manufacturing Sciences and Technology, Quality Assurance, Manufacturing, and Laboratory, to ensure successful validation of systems.
• Perform risk assessments and impact analyses to determine the validation requirements for new and existing systems.
• Maintain validation documentation and ensure it is up-to-date and readily available for audits and inspections.
• Participate in the review and approval of system change controls, deviations, and CAPAs related to computer systems.
• Provide training and guidance to stakeholders on CSV processes and best practices.
• Stay current with industry trends and regulatory updates related to computer system validation.

Qualifications:

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
• Minimum of 2 years of experience in computer system validation within the pharmaceutical, biotechnology, or medical device industry.
• Strong knowledge of regulatory requirements and industry standards related to CSV (e.g., FDA, EMA, GAMP 5, 21 CFR Part 11).
• Experience with validation of various types of systems, including MES, DeltaV, LIMS, ERP, and laboratory instruments.
• Excellent written and verbal communication skills, with the ability to create clear and concise validation documentation.
• Strong analytical and problem-solving skills, with attention to detail.
• Ability to work independently and as part of a team in a fast-paced environment.
• Proficiency in Microsoft Office Suite and validation software tools.

Preferred Qualifications:

• Advanced degree in a related field.
• Experience with cloud-based systems and software as a service (SaaS) validation.
• Knowledge of data integrity principles and practices.
• Certification in computer system validation or related areas (e.g., ASQ, ISPE).

Working Conditions:

• Office and laboratory environment.
• Occasional travel may be required to support validation activities and workshops at other sites.

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.

• Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for computer systems and software applications used in GxP environments.
• Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GAMP 5, 21 CFR Part 11, etc.).
• Collaborate with cross-functional teams, including IT, Manufacturing Sciences and Technology, Quality Assurance, Manufacturing, and Laboratory, to ensure successful validation of systems.
• Perform risk assessments and impact analyses to determine the validation requirements for new and existing systems.
• Maintain validation documentation and ensure it is up-to-date and readily available for audits and inspections.
• Participate in the review and approval of system change controls, deviations, and CAPAs related to computer systems.
• Provide training and guidance to stakeholders on CSV processes and best practices.
• Stay current with industry trends and regulatory updates related to computer system validation