Senior CQV Engineer

Jacobs; Bengaluru; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

Jacobs is seeking a Sr. CQV Engineer/CQV Lead in Bengaluru, India, to manage commissioning and qualification of equipment and systems in drug manufacturing. The ideal candidate will lead CQV engineering teams and ensure compliance with industry standards.

Key responsibilities include preparing C&Q plans, coordinating CQV projects, tracking activities, and liaising between clients and internal teams. Qualified candidates should have a Bachelor’s in engineering or Life Sciences, with 10–15 years of experience in the field.

Qualifications

• 10–15 years’ experience in CQV within the pharmaceutical or biotechnology industry.
• Proven experience carrying out commissioning and qualification activities.
• Functioned as CQV Lead level for at least one project.

Responsibilities

• Lead CQV projects ensuring compliance with regulations.
• Prepare C&Q plans and manage their timely delivery.
• Act as primary contact for clients and internal teams.

Skills

Team leadership

Project management

Problem-solving

Attention to detail

Education

Bachelor’s degree in engineering or Life Sciences

Advanced degree preferred (B.Pharm., M.Pharm., B.Tech or BE or MSc)

Tools

KNEAT

Valgenesis

DCS/PCS systems such as Delta-V

Job description

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 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 requires an experienced, energetic, and committed senior/lead CQV person with broad experience in C&Q, particularly biopharmaceuticals.

The person should have experience 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.
• 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 equipment/systems, facilities and utilities, to identify critical process parameters and control strategies.
• Develop 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.
• Ensure 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.

Qualifications

• 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 years’ experience in CQV within the pharmaceutical or biotechnology industry, specifically in drug substance manufacturing.
• Candidates must have proven experience 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 systems such as Delta‑V, 800xA, etc.
• Familiarity with construction management software such as EIDA, PIMS, Aconex – an advantage.
• Familiarity with paperless validation software such as KNEAT and Valgenesis – 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.