Senior Specialist, Engineering CQV - Cleaning Validation

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Position Summary BMS Cruiserath Biologics is seeking to recruit one permanent Engineering CQV, Sr. Specialist – Cleaning Validation. The role is part of the Engineering Commissioning, Qualification and Validation (CQV) team and will support Cleaning Validation activities across the Multi-Product Cell Culture (MPCC) and Sterile Drug Product Facility (SDPF) sites. The successful candidate will report to the Sr. Manager, Engineering CQV. The role will provide technical leadership and subject matter expertise for the development, execution, and lifecycle management of cleaning validation programmes for manufacturing equipment. The position will ensure cleaning processes are scientifically justified, compliant with applicable regulatory expectations, and maintained in a validated state. Key Responsibilities •  Operate as part of the Engineering CQV team under a campus approach, supporting Cleaning Validation activities across the MPCC and SDPF facilities. •  Act as a Cleaning Validation subject matter expert and provide technical guidance to Engineering, CQV, Manufacturing, Quality Assurance, MS&T, and other relevant functions. •  Develop, maintain, and execute Cleaning Validation master plans, strategies, protocols, and reports for new and existing manufacturing equipment. •  Define scientifically justified cleaning acceptance criteria using health-based exposure limits and applicable product, process, and equipment data. •  Perform and document worst-case product and equipment assessments, including equipment grouping, bracketing, and matrixing strategies where appropriate. •  Develop sampling plans for swab and rinse samples, including selection and justification of sampling locations, methods, and recovery studies. •  Provide Cleaning Validation input to user requirements, design reviews, commissioning and qualification plans, equipment modifications, and start-up activities. •  Assess changes, deviations, cleaning failures, process modifications, and new product introductions for potential impact on the validated state. •  Support investigations, root cause analysis, corrective and preventive actions, and implementation of effective remediation plans. •  Ensure Cleaning Validation documentation is technically accurate, complete, current, traceable, and audit-ready. •  Support continued process verification, periodic review, monitoring, and lifecycle management of the Cleaning Validation programme. •  Identify and implement opportunities for process improvement, standardisation, digital enablement, and enhanced compliance. •  Communicate plans, progress, risks, and results clearly to key stakeholders and governance forums. •  Provide training, coaching, and technical support to team members on Cleaning Validation principles, procedures, and regulatory expectations. Qualifications and Experience •  Bachelor’s degree in Engineering, Life Sciences, Chemistry, Microbiology, or a related technical discipline. •  Demonstrated experience in Cleaning Validation within a pharmaceutical, biopharmaceutical, or other regulated manufacturing environment. •  Strong knowledge of Cleaning Validation principles, including health-based exposure limits, maximum allowable carryover calculations, worst-case selection, equipment grouping, sampling strategies, and cleaning process lifecycle management. •  Knowledge of applicable regulatory requirements and industry guidance, including FDA and EMA expectations, ICH Q7 and ICH Q9, and ASTM E3106. •  Experience authoring and executing Cleaning Validation plans, protocols, reports, risk assessments, and technical justifications. •  Experience assessing deviations, changes, and investigation outcomes for impact on the validated state. •  Strong problem-solving, analytical, risk assessment, and technical writing skills. •  Excellent communication and interpersonal skills, with the ability to influence and collaborate across a multidisciplinary organisation. •  Ability to work independently, manage competing priorities, and contribute effectively as part of a team. •  Proficiency in Microsoft Office and relevant validation or document management systems. •  Experience in biologics manufacturing, sterile drug product operations, or facility start-up is advantageous. Key Competencies•  Technical leadership and subject matter expertise •  Quality and compliance focus •  Risk-based decision-making •  Cross-functional collaboration •  Clear written and verbal communication •  Ownership, accountability, and continuous improvement On-site ProtocolPhysical presence at the BMS worksite is a necessary function of this role and is considered important to collaboration, innovation, productivity, employee well-being, and engagement. We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. How We Work Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. Supporting People with Disabilities 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only:  If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act. Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account. R1608497 : Senior Specialist, Engineering CQV - Cleaning Validation