Job Description
Manager, Engineering Commissioning, Qualification and Validation
Transform the lives of patients and advance your career in a dynamic and innovative environment.
Bristol Myers Squibb is a leading biopharmaceutical company that has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.
The company's Cruiserath Biologics Campus is a state-of-the-art facility that plays a central role in the Global Product Development and Supply (GPS) network, producing multiple therapies for the company's growing biologics portfolio.
The Global Biologics Laboratory (GBL) is responsible for the release testing of Biologics Drug product for the network and is also based on the Cruiserath Biologics Campus.
BMS Cruiserath has been awarded Biopharma Company of the Year 2019 in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017.
Job Description
- Support the Sterile Drug Product Facility project as part of the CQV team responsible for the Lyophilizer qualification.
- Plan, coordinate, and oversee validation activities for validation 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.
Requirements
- Bachelor/Masters in Engineering, or Science related discipline.
- Extensive experience in commissioning and 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.
- 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.
- Experience supporting internal and external audits and inspections related to validation activities, including addressing findings or observations and implementing corrective actions.