Manager, Engineering Commissioning, Qualification and ValidationApply
Location: Cruiserath - IE
Time Type: Full time
Posted On: Posted Yesterday
Job Requisition ID: R1585005
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Position Summary BMS Cruiserath Biologics is seeking to recruit a permanent Manager, Engineering Commissioning, Qualification and Validation. Reporting to the Associate Director, Engineering Commissioning, Qualification and Validation, the successful candidate will initially be part of the Sterile Drug Product Facility (SDPF) project team working within component preparation CQV team. The candidate will be responsible for the qualification and validation of autoclave loads used in the sterilization processes within the SDP facility. Upon completion of the SDP project, responsibilities will shift to a "one campus" approach and this role will expand scope to cover autoclaves and temperature mapping in the drug substance facility. The manager will lead a team of validation specialists, develop and implement validation strategies, and drive continuous improvement initiatives to enhance the efficiency and effectiveness of the sterilization and temperature mapping processes.
Key Responsibilities Support the Sterile Drug Product Facility project as part of the CQV team responsible for the Autoclave qualification. Responsible for the cycle development and PQ execution of the loads required to support MFG operations in SDP.Plan, coordinate, and oversee validation activities for Autoclave projects, ensuring timely completion and adherence to budgetary constraints.Ensure compliance with relevant regulatory requirements, such as FDA, EMA, and GMP guidelines, as well as internal quality standards and procedures.Conduct risk assessments to identify potential hazards and develop mitigation strategies to ensure the safe and reliable operation of systems and processes.Prepare and review validation protocols, reports, and standard operating procedures (SOPs), ensuring accuracy, completeness, and compliance with regulatory guidelines.Collaborate with cross-functional teams, including MS&T, engineering, quality assurance, regulatory affairs, and manufacturing, to ensure alignment and coordination of validation activities with overall project objectives.Develop and implement change control processes, ensuring that any modifications or upgrades to systems and processes are properly validated and documented.Identify opportunities for process improvement and optimization of validation activities, implementing best practices and innovative approaches to enhance efficiency and compliance.Collaborate with external vendors and contractors to ensure proper installation, qualification, and validation of systems and equipment, including review and approval of vendor documentation.Provide training and mentorship to validation team members, promoting professional growth and development.Support internal and external audits and inspections related to validation activities, ensuring compliance and addressing any findings or observations.Qualifications & Experience The successful candidate must possess a Bachelor/Masters in Engineering, or Science related discipline.Extensive experience in Autoclave qualification activities, including developing and implementing validation strategies, managing validation projects, and ensuring compliance with regulatory requirements.Experience in conducting risk assessments and developing mitigation strategies to ensure the safe and reliable operation of systems and processes.Proficiency in preparing and reviewing validation protocols, reports, and standard operating procedures (SOPs) with a strong attention to detail. Excellent technical writing skills are essential.Experience collaborating with cross-functional teams, including engineering, quality assurance, regulatory affairs, and manufacturing, to ensure alignment and coordination of validation activities with overall project objectives.Proven ability to identify opportunities for process improvement and optimization of validation activities, implementing best practices and innovative approaches to enhance efficiency and compliance.Experience supporting internal and external audits and inspections related to validation activities.Previous experience with a biologics startup facility and a good understanding of systems such as Delta V, MES, SAP is desired.Why you should apply You will help patients in their fight against serious diseases.You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.You'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym.#LI-Hybrid 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.
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