Associate Scientist/engineer (validation), Sterile Drug Product Manufacturing, Science & Technology

Associate Scientist/Engineer (Validation), Sterile Drug Product Manufacturing, Science & Technology

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 and Lyophilization sterilization process 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 and/or complexity 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 startup 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

• 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