Description:
BMS Cruiserath Biologics is seeking to recruit a permanent Manager, Engineering Commissioning, Qualification, and Validation (CQV). Reporting to the Senior Manager, Engineering Commissioning, Qualification, and Validation, the successful candidate will join a dynamic team of Computer System Validation (CSV) and CQV engineers, providing comprehensive support to projects throughout the system lifecycle.
The Manager will lead a team of validation specialists, develop and implement robust validation strategies, and drive continuous improvement initiatives to enhance the efficiency and effectiveness of the team and site validation processes. This role is pivotal in ensuring that all systems and equipment meet regulatory and quality standards, thereby supporting the overall mission of BMS Cruiserath Biologics
Key Responsibilities
- Plan, coordinate, and oversee validation activities for CSV and CQV 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 digital plant, 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 the qualification and lifecycle support of GMP systems
- 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.
- Previous experience with a biologics startup facility and a good understanding of systems such as Delta V, MES, SAP is desired.