CQV Lead

EFOR; Munster; On-site; EUR 110,000 - 160,000; Full time

Job summary

EFOR seeks a seasoned CQV Lead to manage end-to-end Commissioning, Qualification, and Validation activities for pharmaceutical manufacturing projects with DeltaV automation. Experience in spray dryer operations is highly preferred.

You will develop CQV documentation, lead cross-functional teams, and ensure GMP readiness for regulatory audits. The role requires strong knowledge of FDA/EMA/ICH guidelines, ISPE/GAMP5 standards, and hands-on DeltaV-controlled process qualification.

Qualifications

• Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, or related discipline.
• 7+ years' CQV experience in pharmaceutical manufacturing (API or secondary manufacturing).
• Proven leadership for commissioning and qualification of DeltaV-controlled processes.
• Hands-on spray drying experience with GMP relevance.

Responsibilities

• Provide technical leadership and oversight for CQV activities on API processes, focusing on spray drying systems integrated with DeltaV automation.
• Develop, review, and execute CQV documentation (IQ/OQ/PQ, commissioning plans, traceability matrices, risk assessments).
• Lead commissioning and qualification for control systems, utilities, and GMP equipment.
• Author DeltaV documents (URS, FDS, SDS); manage FAT/SAT and change controls throughout CQV lifecycle.
• Collaborate with engineering, QA/validation, operations, automation, and regulatory teams to align CQV with project deliverables.

Skills

CQV leadership

DeltaV automation

GMP knowledge

QA/validation

Regulatory compliance

FAT/SAT

Root cause analysis

Data integrity

Education

Bachelor's or Master's degree in Engineering

Tools

DeltaV DCS

ISPE/GAMP5

Job description

• 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.