Lead Process Engineer

Sire Search; Leiden; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Sire Search in the Netherlands is seeking a Lead Process Engineer to optimize production processes in a GMP-regulated environment. You will own day-to-day process performance, identify improvement opportunities, and drive sustainable changes to enhance quality, efficiency, and compliance.

The Senior Manufacturing Process Engineer will collaborate with operations, engineering and quality, handling investigations, assessments, and documentation with a focus on process-related CAPA and PQ

Qualifications

• HBO-level degree in a relevant field.
• 3+ years of production/process engineering experience.
• Strong GMP knowledge in a regulated manufacturing setting.
• Experience with SOPs, work instructions and batch records.
• Experience with deviations, change controls, CAPA and risk assessments.
• Good English communication (minimum B2).
• Proactive, organized and able to handle changing priorities.
• Strong analytical and collaborative-working skills.

Responsibilities

• Support the introduction of new production processes and ensure successful shop-floor implementation.
• Maintain stable operation of existing processes by addressing quality, output, yield and downtime issues.
• Continuously improve processes to raise efficiency and reduce losses.
• Ensure processes operate within validated ranges and regulatory requirements.
• Create, review, and maintain process documentation (SOPs, work instructions, MBRs).
• Perform and support quality risk assessments and periodic document reviews.
• Act as SME for process-related impact assessments.
• Support investigations of deviations and contribute to CAPA ownership.
• Support PQ activities and validation of supporting processes.
• Conduct Gemba walks and lead sustainable improvements in safety, quality, reliability, cost and scheduling.
• Contribute to inspection/audit readiness as a process representative when needed.
• Support continuous process verification and annual product review data gathering.

Skills

GMP knowledge

Process engineering

Documentation

Quality risk assessments

CAPA & deviations

PQ & validation

Gemba walks

Education

HBO-level degree

Job description

Company

Our client is a leading organization in the life sciences sector, operating in a highly regulated manufacturing environment. They are committed to quality, safety, and continuous improvement, and work to strict industry standards such as GMP. The site offers a professional setting where cross-functional collaboration and process optimization are key to ongoing success.

Job Description

We are looking for a Lead Process Engineer to support and improve production processes in a GMP-regulated environment. This role focuses on ensuring smooth day-to-day process performance, identifying improvement opportunities, and driving sustainable changes that enhance quality, efficiency, and compliance. The Senior Manufacturing Process Engineer will work closely with operations, engineering, and quality stakeholders and will take ownership of process-related investigations, assessments, and documentation.

Responsibilities

• Support the introduction of new production processes and/or systems and help ensure successful implementation on the shop floor
• Maintain stable operation of existing production processes by addressing issues impacting quality, output, yield, and downtime
• Continuously evaluate and improve processes to increase efficiency, reduce losses, and support overall production goals
• Ensure processes operate within validated ranges and regulatory requirements, escalating risks and issues when needed
• Create, review, and maintain process documentation such as SOPs, work instructions, and master batch records
• Perform and support quality risk assessments and periodic document reviews
• Act as a subject matter expert for process-related impact assessments
• Support investigations of deviations/non-conformances and contribute to change controls and CAPA ownership
• Support performance qualification (PQ) activities and assist with validation of supporting processes when required
• Conduct Gemba walks, observe operational execution, and lead sustainable improvements in safety, quality, reliability, cost, and scheduling
• Contribute to inspection/audit readiness by providing process input and acting as a process representative when needed
• Support continuous process verification and annual product review activities by gathering data and performing follow-up analysis

Requirements

• Relevant HBO-level degree
• At least 3 years of relevant experience in a production/process engineering environment
• Strong understanding of GMP and working in a regulated manufacturing setting
• Comfortable with documentation standards (SOPs, work instructions, batch records)
• Experience with deviations, change controls, CAPA, and risk assessments is a strong advantage
• Good English communication skills (minimum B2 level)
• Proactive, organized, and able to stay calm under pressure while managing changing priorities
• Strong analytical skills and ability to work both independently and collaboratively

Other Information

The role is based hybrid in Leiden, within a regulated manufacturing environment.

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