Qualification Engineer

Adryan; Zürich; Vor Ort; CHF 80’000 - 110’000; Vollzeit

Zusammenfassung

An established industry player in the life sciences sector is seeking a CQV Engineer to join their dynamic team. In this role, you will be at the forefront of commissioning, qualification, and validation activities for GMP facilities and process equipment. You will ensure compliance with regulatory standards while working collaboratively within a project team. This position offers an exciting opportunity to engage in inspiring projects and contribute to a rapidly growing organization. If you are a proactive problem-solver with a strong background in CQV and a passion for the life sciences, this role is perfect for you.

Leistungen

Training budget

Employee benefits program

Relocation arrangement for non-Swiss candidates

General 2nd class abonnement for Swiss public transportation

Monthly Adryan Team Evening

Internal knowledge sharing program

Qualifikationen

• 5+ years of experience in a GMP environment, preferably in life sciences.
• Bachelor's degree in engineering or related technical field required.

Aufgaben

• Responsible for CQV activities in compliance with regulatory standards.
• Designing and executing C&Q documentation for GMP facilities.

Kenntnisse

cGMP regulations

CQV experience

Problem-solving skills

Communication skills

Interpersonal skills

Teamwork

Customer-oriented mindset

Solution-driven mindset

Ausbildung

Bachelor's degree in engineering or science

ETH/EPFL in chemical or mechanical engineering

Tools

MS Office

Controlled documentation systems

Jobbeschreibung

Commissioning, qualification & validation engineer

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.
• Training budget.
• 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.

Do you want to apply as CQV Engineer?