CQV Lead: DeltaV & Spray Drying Expert

EFOR

Munster

On-site

EUR 110,000 - 160,000

Full time

5 days ago
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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

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.

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