CQV Engineer

EFOR; München; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A leading engineering firm in Munich is seeking a CQV Engineer responsible for commissioning and qualification activities for formulation process equipment. The role involves developing and executing CQV protocols while coordinating activities to ensure compliance with cGMP and regulations. Candidates should have a Bachelor's degree in Engineering and over 5 years of experience in the regulatory industry. A strong focus on safety and project delivery is essential.

Qualifikationen

• 5+ years’ experience as a CQV Engineer in a regulated industry.
• Proven experience with formulation systems.
• Experience with protocol generation & execution.

Aufgaben

• Develop and execute CQV protocols for equipment.
• Coordinate qualification activities per cGMP policies.
• Support project delivery during installation phases.

Kenntnisse

CQV protocols development

Cross-functional teamwork

Problem-solving skills

Knowledge of cGMP and FDA regulations

Ausbildung

Bachelor’s degree in Engineering

Jobbeschreibung

The CQV Engineer (Formulation) is responsible for commissioning, qualification, and validation activities for formulation process equipment and associated utilities within a GMP-regulated environment. This includes ensuring that all systems meet user requirements, functional specifications, and quality standards, with a primary focus on safety, regulatory compliance, and successful project delivery for the following equipment:

Key Responsibilities

• Develop and execute CQV protocols (SAT, IQ, OQ, PQ) for all relevant equipment.
• Coordinate and supervise commissioning and qualification activities in accordance with cGMP and corporate policies.
• Generate and review CQV deliverables (user requirements, functional/design specifications, traceability matrices, test scripts, deviation reports).
• Liaise with vendors and contractors for FAT, SAT, and punch list resolution.

Equipment & Systems in Scope

• CIP Skids and docking stations
• Isolator systems (including hopper and integrated weighing systems)
• Glove tester isolators
• Ventilated Balance Enclosure (VBE)
• Precision weighing scales
• Formulation vessels, inline blenders, and disperser units
• Docking Stations (general and for Solvent Distribution, including Down Flow Booths)
• Particle Filter Skids and Sterile Filter Skids
• Filter Integrity Tester units
• Pass-through chambers
• Heating jackets (for drums and vessels)

Project & Quality Support

• Support project delivery teams, vendors, and site stakeholders during design, installation, and start-up phases.
• Ensure equipment meets regulatory and safety standards.
• Participate in risk assessments (e.g., FMEAs), HAZOPs, and design reviews.
• Support generation and remediation of deviations, discrepancies, and change controls.
• Maintain project documentation in line with Data Integrity principles.

Operational Readiness & Handover

• Assist the transition of qualified systems to operations/production teams.
• Provide technical training, SOP review, and troubleshooting during handover.

Required Qualifications / Skills

• Bachelor’s degree in Engineering (Chemical, Mechanical, Process, or related discipline).
• 5+ years’ experience as a CQV Engineer or similar role in the pharmaceutical, biotech, or related regulated industry.
• Proven experience with formulation systems and relevant process/utility equipment.
• Strong knowledge of cGMP, FDA, and EU regulatory requirements pertaining to commissioning and qualification.
• Experience with protocol generation & execution, deviation management, and technical writing.
• Good problem-solving skills and ability to work effectively in cross-functional teams.