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Principal Engineer/Sr. Principal Engineer - CQV
Jacobs
Karnataka, IND
Full-time
Hybrid
Discovered 1 weeks ago
Commissioning, qualification, and validation (CQV)GxP environmentsRisk-based validationFacility and equipment qualificationPharmaceutical and biotechnology manufacturingGMP compliance
Free
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Commissioning, qualification, and validation (CQV)GxP environmentsRisk-based validation
Role Overview
The role leads end-to-end commissioning, qualification, and validation programs for pharmaceutical, biotechnology, and medical device projects.
The position combines CQV subject matter expertise with project leadership, regulatory compliance, and delivery accountability.
The role requires broad C&Q experience, particularly in biopharmaceuticals, and experience leading CQV engineers on large projects.
Key Skills for This Role
Commissioning, qualification, and validation (CQV)GxP environmentsRisk-based validationFacility and equipment qualificationPharmaceutical and biotechnology manufacturingGMP compliance
Full Job Posting
Role Overview
The role leads end-to-end commissioning, qualification, and validation programs for pharmaceutical, biotechnology, and medical device projects.
The position combines CQV subject matter expertise with project leadership, regulatory compliance, and delivery accountability.
The role requires broad C&Q experience, particularly in biopharmaceuticals, and experience leading CQV engineers on large projects.
Core Responsibilities
- Lead and execute CQV activities across multiple projects in accordance with industry regulations and project timelines.
- Act as technical authority for process equipment, process utilities, automation, HVAC, and controlled environments.
- Manage CQV engineers, vendors, and contractors and serve as the primary interface with clients, design teams, quality, and regulatory teams.
- Track deliverables, budgets, risks, and timelines and resolve escalations with engineering teams and clients.
- Review GMP layouts, P&IDs, URS, FS/DS, equipment specifications, and vendor documentation.
- Mentor junior staff, establish best practices and templates, and drive continuous improvement and knowledge sharing.
- Prepare C&Q plans and ensure commissioning and qualification procedures are implemented at office and site level.
- Develop, review, and execute validation plans and URS, DQ, TM, FAT, SAT, IQ, and OQ protocols and reports.
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