Senior CQV Engineer – GMP Life Sciences Specialist

Adryan; Oregon; Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Company car

Laptop

Phone

Training budget

Bonus scheme

Job summary

Adryan is seeking a seasoned CQV engineer to join the US life sciences team. You will own commissioning, qualification, and validation activities for GMP facilities and critical systems, ensuring regulatory and internal quality compliance.

Responsibilities include designing CQV documentation, IQ/OQ/PQ execution, data analysis, and final reporting. A strong GMP background and 10+ years of experience are preferred in a fast-paced project environment.

Qualifications

• Bachelor’s degree in engineering or related technical field is required or equivalent.
• 10+ years in life sciences/medical devices with CQV exposure preferred.
• Strong understanding of cGMP, regulatory expectations, and quality systems.

Responsibilities

• Lead CQV activities for GMP facilities, equipment, and utility systems.
• Develop, execute, and archive IQ/OQ/PQ and validation protocols and reports.
• Analyze validation data and summarize findings in final reports.
• Recommend test strategies and coordinate validation testing.
• Collaborate with project teams and ensure regulatory compliance.

Skills

CQV expertise

GMP experience

Regulatory knowledge

Documentation proficiency

Team collaboration

Problem solving

Communication skills

Education

Bachelor’s degree in engineering or related field

Tools

MS Office

Controlled documentation systems

Job description

Adryan is recruiting a Commissioning, Qualification & Validation engineer (CQV) for the US Life Science market.

• Job Type: Permanent
• Experience: 10+ years
• Branche: Medical Devices
• 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 (bio)pharmaceutical and high-end food 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. HTS in chemical or mechanical engineering, or an equivalent combination of education and experience
• Proficient with computers (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 biotech industry
• 3+ years of experience with CQV
• Flexible, a team player, a problem solving mindset and positive attitude
• Customer and result-oriented
• Forward-looking attitude and engaging cooperative style
• Good communication and interpersonal skills

Job offer

• A challenging position within a dynamic and rapidly growing organisation.
• Inspiring projects within our life sciences network
• A good salary, depending on education, knowledge and experience.
• An attractive bonus scheme and great benefits, such as a company car, laptop, telephone and a personal training budget so that you can continue to develop yourself.
• 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.