CQV Engineer

EFOR; Wallis; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

EFOR seeks an experienced CQV Engineer to join our pharmaceutical facility in Switzerland. You will lead commissioning and qualification activities for CIP utility systems, ensuring WFI, RO, steam, process air and HVAC meet cGMP standards throughout project delivery.

The role requires 5+ years in CQV within pharma, strong DeltaV automation expertise, and the ability to collaborate with multi-disciplinary teams on site. You will prepare documentation and support regulatory inspections.

Qualifikationen

• Bachelor’s degree in Engineering or related field.
• Minimum 5 years CQV experience in a pharmaceutical or GMP environment.
• In-depth knowledge of CIP utility systems (WFI, RO, Steam, Process Air, HVAC).
• Proven experience with DeltaV automation systems in a pharma setting.
• Proficient in commissioning, qualification, and validation protocol execution (FAT, SAT, IQ, OQ, PQ).
• Strong understanding of cGMP and regulatory requirements for pharmaceutical manufacturing.
• Effective communication, problem-solving and organizational skills.
• Ability to work independently and collaboratively on site.

Aufgaben

• Develop, review, and execute commissioning and qualification protocols (FAT, SAT, IQ, OQ, PQ) for CIP utility systems in a pharmaceutical manufacturing environment.
• Lead commissioning activities for GMP utility systems, including water generation/distribution, steam, compressed air, and HVAC.
• Integrate and validate DeltaV automation platforms, ensuring systems operate reliably in compliance with cGMP.
• Prepare and revise documentation: SOPs, validation plans, engineering drawings, and change controls.
• Collaborate with project teams, vendors, contractors, and cross-functional departments to support timely project execution.
• Troubleshoot and resolve issues during commissioning and qualification, applying risk-based approaches.
• Ensure compliance with local and international pharmaceutical regulations (FDA/EMA/GMP).
• Support regulatory inspections, audits, and provide technical expertise during site visits.
• Advocate for safety and quality practices across all project tasks.

Kenntnisse

CQV experience

DeltaV

GMP awareness

Communication

Problem solving

Ausbildung

Bachelor's degree

Tools

DeltaV automation systems

Jobbeschreibung

We are seeking an experienced CQV (Commissioning, Qualification & Validation) Engineer for our pharmaceutical facility. The successful candidate will focus on Clean-In-Place (CIP) Utilities and must demonstrate proficiency with DeltaV automation systems. This role is integral to ensuring utility systems (including WFI, RO, Steam, Process Air, and CIP) meet GMP and regulatory requirements throughout project delivery.

Key Responsibilities

• Develop, review, and execute commissioning and qualification protocols (FAT, SAT, IQ, OQ, PQ) for CIP utility systems in a pharmaceutical manufacturing environment.
• Lead commissioning activities for GMP utility systems, including water generation/distribution, steam, compressed air, and HVAC.
• Integrate and validate DeltaV automation platforms, ensuring systems operate reliably in compliance with cGMP.
• Prepare and revise documentation: SOPs, validation plans, engineering drawings, and change controls.
• Collaborate with project teams, vendors, contractors, and cross-functional departments to support timely project execution.
• Troubleshoot and resolve issues during commissioning and qualification, applying risk-based approaches.
• Ensure compliance with local and international pharmaceutical regulations (FDA/EMA/GMP).
• Support regulatory inspections, audits, and provide technical expertise during site visits.
• Advocate for safety and quality practices across all project tasks.

Requirements

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical), Science, or related field.
• Minimum 5 years CQV experience in a pharmaceutical or GMP-regulated environment.
• In-depth knowledge of CIP utility systems (WFI, RO, Steam, Process Air, Clean Steam, HVAC).
• Proven experience with DeltaV automation systems in a pharma setting.
• Proficient in commissioning, qualification, and validation protocol execution.
• Strong understanding of cGMP and regulatory requirements for pharmaceutical manufacturing.
• Effective communication, problem-solving, and organizational skills.
• Ability to work both independently and collaboratively on site.