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Position Summary
BMS Cruiserath Biologics is seeking to recruit a permanent Associate Scientist/Engineer (Validation), Sterile Drug Product Manufacturing, Science & Technology. Reporting to the Principal Validation Engineer, Sterile Drug Product Manufacturing, Science & Technology, this role will be the Validation Engineer responsible for all validation aspects of Isolator surface decontamination (VHP), Dry heat tunnel, Lyophilization sterilization process equipment along with all supporting equipment that is being installed in a new Sterile Drug Product Manufacturing Facility being built on the Cruiserath campus. The successful candidate will be part of a multi-functional team charged with the delivery of significant capital investment and will support developing and qualifying sterilization processes to ensure all process equipment meets all regulatory and safety standards. Upon completion of the project, you will continue to support the sustaining operation on site as well as acting as a global Subject Matter Expert (SME) within the organization.
Key Responsibilities
Execution of sterilization validation studies, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Development and execution of allocated validations according to the SDP Validation Master Plan.
Maintain appropriate and comprehensive validation policies and procedures.
Support all technical and equipment validation activities from design to successful PPQ of products within the SDP facility, and after which will support routine production of the facility.
Ensure that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements.
Provide input, monitor, and report compliance on the content of the Validation Master Plan in conjunction with the appropriate Primary teams, and corresponding Management Reviews.
Ensure the review and approval of validation lifecycle documentation and ensure they are written in accordance with the company standards and procedures.
Publish site specific progress reports as required.
Quality of completed validations [Effectiveness, schedule adherence, minimum deviations]
Support site change control procedures
Assist and/or lead low to medium risk complex investigations.
Any other reasonable duties which may be required by management.
Qualifications & Experience
Good technical knowledge of Sterile Drug Product manufacturing equipment validation and sterilisation. Specifically in the areas of sterile filling, Formulation SIP and associated equipment.
Knowledgeable on current industry practices and regulatory requirements within the Sterile Drug Product manufacturing area.
Experience of qualification and validation of Sterile Drug Product manufacturing equipment and/or processes. Specifically in the area of Sterile Filling and Isolator Technology equipment.
The successful candidate must possess a Bachelor/master’s in engineering, or Science related discipline. A minimum of 2 years’ experience within a Sterile Drug Product Manufacturing is essential.
Demonstrated ability to influence work cross functionally in a matrix environment during start-up and into commercial manufacture.
The candidate will have demonstrated proficiency communicating and collaborating at a variety of levels, coupled with excellent organization, planning technical writing skills.
Problem solving and project management ability, as well as lean manufacturing experience is essential.
Ability to work independently and as part of a team.
Contributes to creation of new processes or improvement of existing methods/processes as appropriate.
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.
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.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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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