At Jacobs, we're 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.
Your impact
The CQV Engineer will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes used in the production of Drug substances/ Drug Product/ Sterile Facilities/ API/ OSDs, as well as the Utility system, HVAC system and Area. This role ensures that all systems operate as intended and comply with regulatory standards. The CQV Engineer will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of projects.
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 equipments/ 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 equipments/ 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 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 non-conformances or deviations are minimized during execution of CQV activities. For issues that do arise ensure they are closed out in a timely manner.
- Track and confirm closure of actions items identified through FAT, HAZOP, Design Qualification and other reviews.
- Perform shakedown during commissioning and qualification of systems on site.
- Field Walkdowns of systems as part of transfer of ownership of the system from Construction.
- System Startup activities
- 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.
Working Conditions
- The position requires travel and/ or deputation to other sites or manufacturing facilities.
- Ability to work in a cleanroom environment and adhere to gowning requirements.
- Flexibility to work outside of regular business hours as needed to support project timelines
Here's what you'll need
- Bachelor's degree in engineering, Life Sciences, or a related field. Advanced degree preferred. B. Pharm., M. Pharm., B.Tech or BE or MSc.
- 5-8 year's 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 equipments/ systems, facilities and utilities.
Technical Skills
- Experience with paperless validation software such as KNEAT and/ or Valgenesis.
- Strong understanding of cGMP, FDA, EMA, and other relevant regulatory requirements.
- Experience with process validation and computer system validation.
- Familiar with Delta-V and other PCS/ DCS systems is an advantage.
- Familiarity with Construction management software such as EIDA, PIMS, Aconex, is an advantage
Soft Skills
- Excellent problem-solving and analytical skills.
- Strong project management and organizational skills.
- Effective communication and interpersonal skills.
- Ability to work independently and as part of a team
At Jacobs we value people. Having the right balance of belonging, career and lifestyle enables us to consistently deliver and exceed clients expectations.
Working alongside industry leaders, you will have the opportunity to develop your career working on key projects in an environment which encourages collaboration, knowledge sharing and innovation. To support your professional growth, Jacobs flexible working arrangements, extended leave options and a host of social, health and wellbeing events and initiatives will underpin our commitment to you.
At Jacobs it's all about what you do, not where you are, which counts!
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.
Your application experience is important to us, and we're keen to adapt to make every interaction even better. If you require further support or reasonable adjustments with regards to the recruitment process (for example, you require the application form in a different format), please contact the team via Careers Support.
