BMS Compliance & Systems Engineer – GMP Environments Leiden • SIRE Life Sciences

Location: Leiden, Netherlands (Hybrid)
Contract: 1 year duration, with high likelihood of extension

About Our Client

Our client is a leading global biopharmaceutical manufacturer, with a state-of-the-art production facility in Leiden. Known for producing high-quality biologics across a wide range of therapeutic areas, the organization operates within a highly regulated GMP environment. Their focus on innovation, quality, and operational excellence makes them a key player in the pharmaceutical industry, dedicated to improving patient outcomes worldwide.

About the Role

We are looking for a BMS Compliance & Systems Engineer to strengthen the Execution Systems team supporting critical facility systems at our client’s site in Leiden. In this hybrid role, you’ll focus on managing the compliance, lifecycle, and documentation of Building Management Systems (BMS) and Environmental Monitoring Systems (EMS), as the facility transitions from Priva to Honeywell. The role involves close collaboration with vendors, internal stakeholders, and validation teams, with an emphasis on coordination—not programming or project leadership.

Responsibilities

• Oversee and coordinate the lifecycle management of BMS/EMS systems in a GMP-regulated setting.

• Act as the main point of contact for BMS vendors (e.g., Honeywell, Priva) and internal stakeholders.

• Support validation processes, including FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing).

• Maintain, update, and review technical documentation, SOPs, and work instructions.

• Participate in weekly/bi-weekly system migration meetings and compliance reviews.

• Ensure all systems and documentation meet GMP and GAMP requirements.

• Review and approve vendor documentation in line with internal quality processes.

• Provide technical input and compliance support during audits and inspections.

Requirements

• Technical degree (HBO level or higher) in Industrial Automation, Electrical Engineering, or a related field.

• 3+ years of hands-on experience with BMS systems in a GMP environment.

• Experience with Honeywell or Priva systems is strongly preferred.

• Strong knowledge of system lifecycle documentation and compliance processes.

• Fluent in English (written and verbal); Dutch is a plus but not required.

• Familiarity with GAMP guidelines and pharmaceutical validation practices.

• Experience managing external vendors and integrators.

• Required certifications: VCA and NEN 3140.

• Detail-oriented, communicative, and team-driven with a structured working style.

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