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Your impact
The Sr. CQV Engineer/ CQV Lead will be responsible for leading the efforts for commissioning, qualification, and validation of equipment/ systems, and processes in the production of Drug substances/ Drug Product/ Sterile Facilities/ API/ OSDs, as well as the Utility system, HVAC system and Area.
The role will require the leadership of an experienced, energetic, and committed Senior/ Lead CQV person with broad experience in C&Q, particularly biopharmaceuticals.
The person should have experience of leading a team of CQV engineers for a project and managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion. The lead will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of projects.
Key Responsibilities
- Lead and coordinate CQV projects, ensuring timely execution and compliance with industry regulations.
- To prepare C&Q plans in line with the strategic goals of the client and manage timely and compliant delivery of the plan.
- Ensure all commissioning and qualification procedures are implemented and adhered to at office and at site level.
- Track progress of C&Q activities as required and provide regular project updates and status reports to stakeholders.
- Ensure effective resource planning, including coordinating materials, spares and consumables for commissioning and qualification activities.
- Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
- Provide leadership in team meetings and facilitate problem-solving discussions to ensure project milestones are met.
- Act as the primary point of contact between clients, internal teams, and external vendors to drive project success.
- Management of Contractors and Vendors, document control, punch list management.
- Participate in design, constructability, and commissioning reviews to ensure technical aspects are covered in the Commissioning Plan and schedule.
- Well versed with risk-based approaches to C&Q (e.g., ASTM E2500, ISPE)
- Conduct risk assessments and gap analysis for process equipments/ systems, facilities and utilities, to identify critical process parameters and control strategies.
- Developing system boundaries for the system at an early stage of C&Q.
- Complete the development, review and execution of validation plans, URSs/DQ/TMs/FATs/SATs/IQ/OQ protocols/reports.
- Experienced in commissioning and qualifying CIP & SIP systems.
- Participate in design document reviews and ensure that quality aspects are included in design.
- Review vendor documents (CTOPs/ VTOPs) to support commissioning and qualification requirements.
- Ensures C&Q 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
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.
- 10-15 year's experience in CQV within the pharmaceutical or biotechnology industry, specifically in drug substance manufacturing.
- Candidates must have proven experience of carrying out commissioning and qualification activities on multiple projects.
- Have functioned as CQV Lead level for at least one Project.
Technical Skills
- Experience with paperless validation software such as KNEAT and/ or Valgenesis.
- In-depth knowledge of cGMP, FDA, EMA, and other relevant regulatory requirements.
- Strong project management skills with the ability to handle multiple priorities across national and international locations.
- Experience with process validation and computer system validation.
- Experience on DCS/ PCS system such as Delta-V, 800xA, etc.
- Familiarity with Construction management software such as EIDA, PIMS, Aconex, is an advantage.
- Familiarity with paperless validation software such as KNEAT and Valgenesis is an advantage.
Soft Skills
- Strong problem-solving skills, attention to detail, and a results-oriented mindset.
- 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.
