CQV Lead

EFOR; Munster; On-site; EUR 90,000 - 120,000; Full time

Job summary

EFOR is seeking a CQV Lead to manage end-to-end Commissioning, Qualification and Validation for API processes, with emphasis on DeltaV automation and spray drying systems. You will lead cross-functional CQV teams, author QC documentation, and drive regulatory compliance in GMP environments.

The role requires a minimum of 7 years in CQV, strong knowledge of FDA/EMA guidelines, and hands-on spray dryer qualification experience within pharmaceutical manufacturing.

Qualifications

• 7+ years in CQV in pharmaceutical manufacturing.
• Experience with API or secondary manufacturing.
• Hands-on qualification experience with DeltaV-controlled processes.

Responsibilities

• Provide technical leadership for CQV activities on API equipment, focusing on spray drying with DeltaV automation.
• Develop, review and execute CQV documentation (IQ/OQ/PQ, commissioning plans, traceability matrices, risk assessments).
• Ensure cGMP, ICH Q7, GAMP5, 21 CFR Part 11 compliance across CQV activities.
• Lead/coordinate commissioning and qualification for control systems, utilities, and process equipment in GMP environments.
• Author and approve DeltaV documents (URS, FDS, SDS), and manage FAT/SAT, deviations, and change controls.
• Collaborate with engineering, QA/validation, regulatory, and operations teams to align CQV with deliverables.
• Lead troubleshooting and root cause analysis for DeltaV systems and data integrity issues.
• Ensure documentation supports GMP readiness for regulatory audits/inspections.
• Supervise contractors and vendor reps for installation start-up and qualification.
• Support technology transfer and training for process and manufacturing teams.

Skills

Project leadership

Regulatory knowledge

DeltaV automation

Spray drying equipment

CQV experience

GAMP5 knowledge

Education

Bachelor’s or Master’s degree in Engineering / Pharmaceutical Sciences

Tools

DeltaV

Job description

Position Summary

• The CQV Lead will be responsible for the end-to-end management of Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical manufacturing projects involving API (Active Pharmaceutical Ingredient) processes. Primary emphasis is on automated systems utilizing Emerson DeltaV Distributed Control Systems, with a strong preference for candidates with experience in pharmaceutical spray dryer operations.

Key Responsibilities

• Provide technical leadership and oversight for CQV activities on API pharmaceutical process equipment, with focus on spray drying systems integrated with DeltaV automation.
• Develop, review, and execute CQV documentation, including commissioning plans, traceability matrices, risk assessments, and IQ/OQ/PQ protocols and final reports, ensuring full compliance with industry standards (cGMP, ICH Q7, GAMP5, 21 CFR Part 11).
• Direct and coordinate commissioning and qualification efforts for control systems, utility interfaces, and process equipment within pharmaceutical GMP environments.
• Author and approve DeltaV-specific documents (URS, FDS, SDS), lead/participate in FAT/SAT, and manage issue logs, deviations, and change controls throughout the CQV lifecycle.
• Collaborate cross-functionally with engineering, QA/validation, operations, automation, and regulatory teams to align CQV execution with project deliverables and regulatory expectations.
• Lead troubleshooting and root cause analysis for DeltaV-controlled systems, process equipment, and associated data integrity matters.
• Ensure thorough and detailed documentation to support GMP readiness for regulatory audits/inspections.
• Supervise contractors and vendor representatives for installation, start-up, and qualification activities.
• Support operational readiness, technology transfer, and training for process and manufacturing teams.

Qualifications and Experience Required

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Process), Pharmaceutical Sciences, or related discipline.
• Minimum of 7 years’ experience in CQV in the pharmaceutical manufacturing sector, with executed projects involving API or secondary manufacturing.
• Proven project leadership for commissioning and qualification of DeltaV-controlled processes.
• Hands-on experience with spray drying equipment – ideally with direct qualification and GMP batch relevance.
• Strong knowledge of global pharmaceutical regulations (FDA, EMA, ICH, WHO), cGMP practices, and applicable standards (ISPE, GAMP5, 21 CFR Part 11).
• Demonstrated success leading multidisciplinary CQV teams and interfacing with internal and external stakeholders.