Principal Engineer/Sr. Principal Engineer - CQV

Jacobs; Gurugram District; Hybrid; INR 1,500,000 - 2,000,000; Full time

Benefits offered by this job

Flexible working arrangements

Extended leave options

Social and wellbeing events

Job summary

Jacobs is seeking a Design Manager - CQV in Gurugram District, India, responsible for leading and delivering validation programs for pharmaceutical projects. This role combines technical expertise with project leadership, ensuring compliance with global standards.

The ideal candidate will have over 15 years of experience in CQV, focusing on drug substance manufacturing, and possess strong stakeholder management skills. The position offers flexible working arrangements and opportunities for growth.

Qualifications

• 15+ years’ experience in CQV within the pharmaceutical or biotechnology industry.
• Deep experience in GxP environments and facility/equipment qualification.
• Strong technical subject matter expertise in CQV.

Responsibilities

• Lead and execute CQV activities across multiple projects.
• Manage multi-disciplinary teams, including engineers and contractors.
• Serve as the primary CQV interface with clients and stakeholders.
• Prepare C&Q plans aligning with client strategic goals.

Skills

Leadership in CQV activities

Regulatory compliance

Risk-based validation

Stakeholder management

Education

Bachelor’s degree in engineering or Life Sciences

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

Job description

Design Manager - CQV

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.

Responsibilities

• 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 equipment, 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.
• Participate 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), industry standards (e.g., ISPE, ASTM) and meet data integrity (ALCOA+) principles. Well versed in commissioning and qualifying CIP & SIP systems.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or a related field. Advanced degree preferred (B. Pharm., M. Pharm., B.Tech, BE, MSc).
• 15+ years’ experience in CQV within the pharmaceutical or biotechnology industry, specifically in drug substance manufacturing.
• Deep experience in GxP environments, risk‑based validation, and facility/equipment qualification.
• Strong stakeholder and team management skills.

Benefits

• Flexible working arrangements and hybrid working policy.
• Extended leave options.
• Social, health and wellbeing events and initiatives.