Lead Process Engineer, GMP Manufacturing (Hybrid)

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

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