Jacobs
Website:
jacobscomm.com
Company:
https://www.linkedin.com/company/jacobs
Seniority: Not Applicable
Industries: Business Consulting and Services
Job details:
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
Design Manager-CQV is responsible for leading and delivering end-to-end commissioning, qualification, and validation (CQV) programs for pharmaceutical, biotechnology, and medical device projects. This role combines technical subject matter expertise with project leadership, ensuring compliance with global regulatory standards while meeting project timelines, quality, and budget targets.
The role requires deep experience in GxP environments, risk-based validation, and facility/equipment qualification, along with strong stakeholder and team management skills. The role will require an experienced, energetic, and committed CQV person with broad experience in C&Q, particularly biopharmaceuticals and having experience of >15 years. The person should have experience of leading CQV engineers for big projects and managing the C&Q documentation and execution lifecycle, from SLIA generation through to OQ/ PQ completion. They will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of projects.
- Lead and execute CQV activities across multiple CQV projects, ensuring timely execution and compliance with industry regulations.
- Act as an SME for CQV having technical authority for systems such as process equipments, process utilities, automation, HVAC and controlled environments.
- Manage multi-disciplinary teams including CQV engineers, vendors, and contractors.
- Serve as the primary CQV interface with clients, design teams and Quality & regulatory teams.
- Track project deliverables, budgets, risks, and timelines and provide regular project updates and status reports to stakeholders.
- Drive decision-making and resolve escalations with engineering team and client.
- Involve in GMP review of layouts and systems and ensure CQV requirements are embedded early in the design lifecycle.
- Review P&IDs, layouts, URS, FS/DS, equipment specifications and vendor documentation.
- Mentor and guide CQV engineers and junior staff.
- Establish best practices, templates, and standard methodologies.
- Drive continuous improvement and knowledge sharing within the team.
- 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.
- Complete the development, review and execution of validation plans, URSs/DQ/TMs/FATs/SATs/IQ/OQ protocols/reports.
- Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM) and meets data integrity (ALOCOA+) principles. Well versed in commissioning and qualifying CIP & SIP systems
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.
- 15+ year’s experience in CQV within the pharmaceutical or biotechnology industry, specifically in drug substance manufacturing.
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.
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