Process Engineer

SIRE® Life Sciences ?; Boxmeer; On-site; EUR 52,000 - 75,000; Full time

Job summary

A leading company in healthcare based in Boxmeer is seeking an experienced professional to oversee filling and freeze-drying processes for vaccines. The role encompasses technical expertise in project management, compliance, and process optimization within a sterile production environment. Candidates should possess an HBO or Vapro C education, extensive production experience, and strong knowledge of GMP protocols. Fluency in Dutch and English is required. This full-time position offers the opportunity to lead impactful projects and contribute to continuous improvement.

Qualifications

• HBO or Vapro C education or willingness to complete.
• Extensive experience in a production environment.
• Strong knowledge of GMP, SHE, and process automation.
• Strong data analysis and problem-solving skills

Responsibilities

• Oversee filling and freeze-drying processes for vaccines.
• Draft and maintain SOPs and Change Control documentation.
• Manage validation and maintenance activities according to GMP protocols.
• Provide training to upskill Senior Operators.
• Serve as backup for Operational Coach, making functional decisions and acting as point of contact.
• Manage validation, calibration, and maintenance activities according to GMP protocols.
• Write URS for new equipment and conduct feasibility screenings.
• Maintain production data in SAP and ensure accurate BOM and capacity planning.
• Conduct GMP and SHE inspections and assist during audits.
• Provide training and develop materials to upskill Senior Operators.
• Participate in Tier meetings and continuous improvement initiatives (Kaizen, SPS).

Skills

Production environment experience

GMP knowledge

Process automation

Proficiency in SAP

Fluent in Dutch and English

English language

Education

HBO or Vapro C education

Tools

Trackwise

Hermes

Hermes

Job description

Our client is a leader in global healthcare with a strong presence in the Netherlands, working on both human and animal health innovations.

About the Role

This role is part of the Filling Production Unit (FPU) and involves overseeing filling and freeze‑drying processes for vaccines and pharmaceutical products. The position combines technical expertise, project management, and process optimisation to ensure compliance, efficiency, and continuous improvement within a sterile production environment.

Responsibilities

• Participate in product transfers, optimisations, and troubleshooting across sites and R&D.
• Collect and analyse data for root cause analysis and trend identification.
• Lead or support projects involving equipment adaptation, material changes, and process improvements.
• Draft and maintain SOPs, BMIs, work instructions, and Change Control documentation.
• Serve as backup for Operational Coach, making functional decisions and acting as point of contact.
• Manage validation, calibration, and maintenance activities according to GMP protocols.
• Write User Requirement Specifications (URS) for new equipment and conduct feasibility screenings.
• Maintain production data in SAP and ensure accurate BOM and capacity planning.
• Conduct GMP and SHE inspections and assist during audits.
• Provide training and develop materials to upskill Senior Operators.
• Participate in Tier meetings and continuous improvement initiatives (Kaizen, SPS).

Requirements

• HBO or Vapro C education (e.g., HLO/HTS, microbiology, (bio)chemistry, process technology) or willingness to complete.
• Extensive experience in production environment.
• Strong knowledge of GMP, SHE, and process automation.
• Proficiency in SAP, Trackwise, Hermes, and other production systems.
• Fluent in Dutch and English (spoken and written).
• Familiarity with hazardous substances and GMO legislation.

Other Information

Opportunity to lead projects and contribute to continuous improvement.

Seniority level

• Associate

Employment type

• Full‑time

Job function

• Health Care Provider, Quality Assurance, and Research

Industries

• Hospitals and Health Care, Veterinary Services, and Biotechnology Research