CQV Lead: DeltaV & Spray Drying Specialist

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

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.