Job
Description
Role Overview: At Jacobs, you will be challenging today to reinvent tomorrow by solving the world's most critical problems for thriving cities, resilient environments, mission-critical outcomes, operational advancement, scientific discovery, and cutting-edge manufacturing, turning abstract ideas into realities that transform the world for good. Key Responsibilities: - Familiarity with risk-based approaches to C&Q (e.g., ASTM E2500, ISPE). - Develop and execute commissioning and qualification lifecycle protocols for new and existing process equipment/systems, facilities, and utilities. - Prepare C&Q plans in line with the strategic goals of the client and as per regulatory requirements. - Experienced in commissioning and qualifying CIP & SIP systems. - Conduct risk assessments and gap analysis for process equipment/systems, facilities, and utilities, to identify critical process parameters and control strategies. - Participate in design document reviews and ensure that quality aspects are included in the design. - Developing system boundaries for the system at an early stage of C&Q. - Review vendor documents (CTOP/ VTOPs) to support commissioning and qualification requirements. - Ensure validation non-conformances or deviations are minimized during the execution of CQV activities. For issues that do arise, ensure they are closed out in a timely manner. - Track and confirm closure of action items identified through FAT, HAZOP, Design Qualification, and other reviews. - Perform shakedown during commissioning and qualification of systems on-site. - Supervise vendors/contractors on-site during commissioning activities. - Ensure compliance with current industry regulations and guidelines relating to Commissioning, qualification, and validation. - Prepare and maintain detailed documentation, including protocols, reports, and standard operating procedures (SOPs). - Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM). - Coordinate with cross-functional teams to ensure seamless project execution. - Provide regular project updates and status reports to stakeholders. Qualification Required: - Bachelor's degree in engineering, Life Sciences, or a related field. Advanced degree preferred. - At least 4 years of experience in CQV within the pharmaceutical or biotechnology industry, specifically in drug substance manufacturing. - Experience with writing and executing commissioning, qualification, and validation of biopharmaceutical equipment and systems (e.g., bioreactors, chromatography systems, filtration systems). - Experience in preparing Risk assessments for new and existing process equipment/systems, facilities, and utilities. Additional Company Details: We value collaboration and believe that in-person interactions are crucial for both our culture and client delivery. We empower employees with our hybrid working policy, allowing them to split their work week between Jacobs offices/projects and remote locations enabling them to deliver their best work.,
