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Commissioning & Qualification Engineer III

SIRE® Life Sciences 🧬

Haarlem
Full-time
5-10 years experience
Hybrid

Key Skills

Change Control
Change Management
GMP Compliance
Impact Assessment
Commissioning
Quality Systems
Safety Systems
Documentation
Stakeholder Coordination
Project Tracking
HVAC
Utilities
Fire Safety Systems
Veeva

Job Description

Company Our client is a leading organisation in the pharmaceutical and life sciences sector, operating in a highly regulated environment where quality, safety, and compliance are critical. The site supports ongoing improvement and investment projects, requiring strong coordination between engineering, quality, and safety stakeholders. The organisation offers a professional setting with multiple projects running in parallel and a strong focus on documented ways of working. Job Description For our client in Haarlem, we are looking for a Commissioning & Qualification Engineer III. This role focuses on managing and coordinating changes within quality and safety systems, ensuring each change is properly assessed, approved, documented, and closed. In addition, the specialist supports commissioning activities for facility infrastructure and technical assets in a live operational environment. Responsibilities Lead and coordinate the full change control process from initiation through approval, follow-up, and closure. Perform pre-assessments and impact assessments to determine how proposed changes may affect GMP processes, safety, operations, and related documentation. Work closely with stakeholders such as Quality, Safety, Engineering, and technical asset owners to collect input and align on next steps. Ensure change records are complete, accurate, and traceable, with clear supporting documentation. Support commissioning activities related to facility and utility assets (e.g., HVAC, utilities, and fire safety systems), including coordination of required information and alignment with internal teams. Track progress across multiple ongoing projects and keep actions moving in a structured and timely way. Requirements Proven experience with change control / change management in a regulated environment (preferably GMP). Experience working with quality and safety systems (experience with Veeva is a strong advantage). Comfortable performing impact assessments and coordinating approvals with multiple stakeholders. Strong documentation skills and a structured, detail-focused way of working. Able to work independently, take ownership, and communicate clearly with both technical and non-technical colleagues. Fluent in English (Dutch is a plus). Other Information The role is based in Haarlem and involves close collaboration with on-site stakeholders in Quality, Safety, and Engineering. Hybrid working may be possible depending on the project needs and team agreements. If you are interested and want to apply, please submit your application via the apply button below and contact me.

Core Responsibilities

Lead change control from initiation through assessment, approval, follow-up, and closure, ensuring records are complete and traceable. Coordinate with Quality, Safety, Engineering, and asset owners, and support commissioning of facility and utility assets while tracking actions across concurrent projects.

Requirements

Candidates should have proven change control or change management experience in a regulated environment, preferably GMP, and experience with quality and safety systems; Veeva experience is an advantage. They should be skilled in impact assessments, documentation, stakeholder coordination, independent ownership, and clear communication, with fluent English; Dutch is a plus.

About SIRE® Life Sciences 🧬

Industry: Biotechnology Research

Company size: 201-500 employees

SIRE® Life Sciences is the market-leading partner for Life Sciences consultancy, project management, and secondment services in the Netherlands. We specialize in connecting expert consultants and project managers with leading biotech, pharmaceutical, medical device, clinical research, and food technology organizations. Our services include: - Life Sciences recruitment & executive search - Interim management & secondment - SOW-based project outsourcing & delivery - RPO (Recruitment Process Outsourcing) - MSP workforce management & vendor-neutral solutions - GMP, GCP, GLP compliance staffing - Clinical research & regulatory affairs resourcing With 100,000+ professionals in our network and 25+ years of experience, SIRE® Life Sciences delivers measurable results for regulated organizations across the Netherlands and Europe. We work with pharma, biotech, medical device, CDMO, CRO, and food technology companies at every stage of the product lifecycle. What sets us apart: - Deep domain expertise in Life Sciences & regulated industries - Full compliance with GxP, ISO, WAADI, and Dutch labour law - Flexible engagement models: permanent, interim, project (SOW), and managed services - Proven delivery track record across Pharma, Biotech, MedTech & Food Science Based in Leiden Bio Science Park, Netherlands. www.sire-search.com

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