CQV Engineer

Adryan B.V; Schweiz; Vor Ort; EUR 96.763 - 129.018; Vollzeit

Benefits dieser Stelle

Relocation arrangement for non-Swiss

Employee benefits program

Public transportation pass

Zusammenfassung

Adryan is recruiting a hands-on CQV engineer to join our project team for the Swiss and Western European life sciences market. You will lead commissioning, qualification and validation activities for GMP facilities and critical systems, ensuring documentation and regulatory compliance.

The role requires a Bachelor in engineering or science, 5+ years GMP experience, 3+ years CQV, and strong communication and teamwork.

Qualifikationen

• Bachelor’s degree in engineering, science or related technical field (e.g., ETH/EPFL).
• Proficient with MS Office and controlled documentation/data systems.
• 5+ years of experience in a GMP environment (life sciences preferred).
• 3+ years of CQV experience.
• Strong communication and teamwork skills.

Aufgaben

• Accountable for all CQV activities as required by schedule and project timelines.
• Provide support in a timely, efficient and quality manner.
• Design, develop, execute, write and archive C&Q documentation (IQ/OQ/PQ) per standards.
• Analyze validation data and summarize findings in final reports.
• Identify GMP requirements for validation during design.
• Resolve protocol/discrepancies and plan follow-ups.
• Make recommendations on test strategies and approaches.
• Coordinate validation testing and maintain team collaboration.

Kenntnisse

MS Office

GMP knowledge

CQV experience

Communication skills

Team player

Customer oriented

Ausbildung

Bachelor's degree in engineering/science

Jobbeschreibung

Adryan is recruiting a CQV engineer for the Swiss and Western European Life Science market.

• Job Type: Permanent
• Experience: 5+ years
• Branche: Life sciences industry
• Area of expertise: Commissioning, Qualification & Validation

Adryan is an internationally operating services group. From our offices in The Netherlands and Switzerland, we offer a full range of services for the life sciences industry. We are specialised in the areas of project management, engineering, CQV and compliance.

As a hands‑on CQV engineer, you are part of a project team and are responsible for the commissioning, qualification and validation activities of GMP facilities, process equipment and critical building and utility systems within our client’s life sciences production facility. This includes the design, implementation and documentation of these qualifications and their lifecycle management, in compliance with all applicable regulatory and internal quality standards (FDA and/or EU regulations).

Key responsibilities:

• Within a smoothly running project team, you’ll be accountable for all aspects of CQV activities as required by schedule and project timelines.
• Providing the required support in a timely, efficient and quality manner.
• Designing, developing, executing, writing and archiving C&Q documentation, such as systems commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) (IOPQ) and validation protocols and reports, according to quality standards and guidelines for the life sciences industry.
• Analysing and interpreting validation data and results, and summarising findings in final reports.
• Analysing the design to identify the GMP requirements for validation.
• Resolving protocol and execution discrepancies, finding a satisfactory conclusion and planning follow-up actions as required
• Making recommendations and decisions (when appropriate) regarding test strategies and approaches
• Conducting and coordinating validation testing
• Maintaining good contact with team members, sharing knowledge, and troubleshooting.

Job requirements

• Bachelor’s degree in engineering, science or related technical field, e.g. ETH/EPFL in chemical or mechanical engineering, or an equivalent combination of education and experience
• Proficient with software (MS Office). Solid understanding of controlled documentation and data systems.
• In-depth knowledge of cGMP regulations.
• 5+ years of experience within a GMP environment, preferably within the life sciences industry
• 3+ years of experience with CQV
• Flexible team player with a solution driven mindset & positive attitude.
• Customer and result-oriented
• Forward-looking attitude.
• Good communication and interpersonal skills

Job offer

• Challenging position within a dynamic and rapidly growing organisation.
• Inspiring projects within our life sciences network
• Attractive salary, depending on education, knowledge and experience.
• Attractive social contributions scheme (high nett retention)
• General 2nd class abonnement for Swiss public transportation
• Employee benefits program
• Internal knowledge sharing program
• Relocation arrangement for non-Swiss candidates
• Monthly Adryan Team Evening
• Being part of our motivated, dedicated and cooperative Adryan team, with a helpful back office that allows you to focus on your role and project.