CQV Engineer

Jacobs; Gurugram District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Jacobs is looking for a CQV Engineer in Gurugram, India, to manage the commissioning, qualification, and validation of pharmaceutical equipment and systems. Ideal candidates will have 5-8 years of experience in the biotechnology industry, ensuring systems comply with regulatory standards such as FDA and EMA.

Candidates should possess a Bachelor's degree in engineering or Life Sciences and must demonstrate strong project management and problem-solving skills. The role includes supervising contractors and coordinating cross-functional teams.

Qualifications

• 5-8 years’ experience in CQV within the pharmaceutical or biotechnology industry.
• Experience with commissioning, qualification, and validation of biopharmaceutical equipment.
• Experience in preparing risk assessments for process equipment and utilities.

Responsibilities

• Responsible for commissioning, qualification, and validation of equipment and systems.
• Ensure compliance with regulatory standards.
• Coordinate with cross-functional teams for project execution.

Skills

Problem-solving

Analytical skills

Project management

Effective communication

Interpersonal skills

Education

Bachelor’s degree in engineering or Life Sciences

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

Tools

KNEAT

Valgenesis

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 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.
• Develop 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 action 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 years’ 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.