Commissioning Engineer

NES Fircroft; Breda; On-site; EUR 70,000 - 95,000; Full time

Job summary

NES Fircroft is seeking an experienced Commissioning, Qualification & Validation (CQV) Engineer to support site engineering projects within a GMP-regulated pharmaceutical manufacturing environment. You will report to the Senior Manager, Validation & Compliance and lead CQV activities for new and existing manufacturing systems.

The role requires hands-on CQV experience, particularly with secondary packaging systems, print and inspection technologies (Systech, Cognex), and strong CSV knowledge.

Qualifications

• Minimum 3 years' CQV experience in pharma/biotech.
• Hands-on experience with secondary packaging equipment.
• Experience with CSV and validation lifecycle in GMP.
• Strong documentation and report writing.

Responsibilities

• Develop, review and maintain CQV documentation including plans and protocols.
• Lead commissioning, qualification and validation activities for manufacturing systems.
• Provide CQV expertise to project teams and ensure GMP compliance.
• Identify and resolve technical and compliance challenges to keep projects on track.

Skills

Technical writing

Communication skills

Analytical thinking

Project prioritisation

Tools

Systech

Cognex

CSV

Job description

We are seeking an experienced Commissioning, Qualification & Validation (CQV) Engineer to support site engineering projects within a GMP-regulated pharmaceutical manufacturing environment. Reporting to the Senior Manager, Validation & Compliance, you will play a key role in delivering commissioning, qualification, and validation activities for technical projects, ensuring compliance with regulatory requirements, company procedures, and customer expectations.

This position requires a hands-on CQV professional with experience in secondary packaging systems, computerized systems validation, and GMP manufacturing operations.

Key Responsibilities

Validation Documentation

• Develop, review, and maintain CQV documentation, including:
• System Criticality Assessments (SCAs)
• Validation Plans
• Commissioning & Qualification Plans (C&Q)
• Test Protocols
• Requirements Traceability Matrices (RTMs)
• Commissioning, Qualification, and Validation Summary Reports
• Lead and execute commissioning, qualification, and validation activities for new and existing manufacturing systems.
• Develop and implement testing strategies aligned with project requirements and established CQV methodologies.
• Ensure all validation activities are performed in accordance with GMP standards, site procedures, and project timelines.

Technical Support & Project Delivery

• Provide CQV expertise and guidance to project teams throughout project execution.
• Ensure technical solutions are implemented in accordance with approved validation strategies and site SOPs.
• Support the successful delivery of project phases including design, development, implementation, testing, commissioning, and validation.
• Identify, elevate, and help resolve technical and compliance-related challenges to maintain project progress.

Required Experience & Qualifications

• Minimum 3 years' experience executing CQV activities within the pharmaceutical or biotechnology industry.
• Hands-on experience commissioning and qualifying secondary packaging equipment.
• Experience with Secondary Packaging Systems, including print and inspection technologies such as Systech and Cognex.
• Strong knowledge of Computerized Systems Validation (CSV).
• Good understanding of validation lifecycle methodologies and GMP requirements.
• Ability to understand how individual validation deliverables contribute to overall project and compliance objectives.

Preferred Skills

• Ability to work independently with minimal supervision in a fast-paced project environment.
• Strong technical writing and documentation skills.
• Excellent verbal and written communication skills.
• Effective stakeholder and customer relationship management abilities.
• Strong analytical and critical-thinking skills.
• Proven ability to prioritise activities and manage competing deadlines.
• Experience working within a GMP-regulated environment, including compliance with applicable procedures, policies, and regulatory requirements.
• Demonstrated ability to anticipate, assess, and resolve project issues through a combination of technical knowledge and business awareness.

Location & Availability

• This is a highly specialised, business-critical position requiring a strong on-site presence.
• Candidates must be willing and able to work on-site 4-5 days per week.
• Successful applicants should be based in, or willing to relocate to, the Breda region.
• Relocation should be achievable within 30-40 days maximum from offer acceptance.
• Due to project timelines, we are particularly interested in candidates who are available to start at short notice or ASAP.