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BMS Cruiserath Biologics is seeking to recruit a Senior Manager, Engineering Commissioning, Qualification and Validation (CQV) on a 12-month fixed term contract. Reporting to the Associate Director, Engineering CQV, the Senior Manager will lead a team of CQV engineers to ensure continuity of supply of medicines for our patients. The successful candidate will support sustaining drug substance CQV operations.
Key Responsibilities
· Support the MPCC Facility responsible for the lifecycle validation of Equipment and Cleaning Validation.
· Responsible for the requalification of clean utilities (WFI and process gases), clean rooms and downflow booths.
· Responsible for the temperature mapping activities for the MPCC, LOC and WCL.
· Leading the Clean in Place team to deliver on cleaning monitoring program and validation of the cleaning cycles for new products.
· Plan, coordinate, and oversee validation activities for multiple 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.
· Manage a team of validation engineers, providing guidance, training, and support to ensure efficient and effective execution of validation activities.
· Collaborate with cross-functional teams, including 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 validation activities, including developing and implementing validation strategies, managing validation projects, and ensuring compliance with regulatory requirements. Ideally, this experience should cover a range of validation activities, such as equipment qualification, HVAC/ Clean room C&Q and computer system validation.
· Proven experience in leading and managing teams, including providing guidance, training, and support to validation professionals. Strong project management skills, including the ability to plan, coordinate, and oversee validation activities across multiple projects.
· Experience in conducting risk assessments and developing mitigation strategies to ensure the safe and reliable operation of systems and processes. Demonstrated ability to ensure compliance with regulatory requirements and internal quality standards.
· 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.
· Strong verbal and written communication skills, including the ability to effectively communicate complex validation concepts to both technical and non-technical stakeholders. Experience presenting validation strategies and results to management and regulatory authorities.
· Experience supporting internal and external audits and inspections related to validation activities, including addressing findings or observations and implementing corrective actions.
Why you should apply
#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 a supportive culture, promoting global participation 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
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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/
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R1599617 : Senior Manager - Engineering Commissioning, Qualification and Validation