Senior GMP Automation Engineer - Bioprocess & MES Expert

Wacker Chemie AG

Amsterdam

Hybrid

EUR 120,000 - 150,000

Full time

9 days ago
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Benefits offered by this job

Attractive salary
Holiday allowance
Home-office travel allowance
Pension plan

Job summary

Wacker Chemie AG in Amsterdam seeks a GMP Automation & Process Engineer to ensure reliable, compliant operation of software-controlled bioprocesses in a GMP manufacturing setting. You will own automation systems, drive lifecycle management, and interface across Operations, Engineering, Quality and IT.

Ideal candidates bring 10+ years in GMP environments, deep ISA-88 and DeltaV experience, and a strong background in batch execution, validation, and process optimization.

Qualifications

  • Advanced degree and 10+ years in GMP-regulated bio/pharma or related manufacturing.
  • Deep experience with process automation and software lifecycle in regulated industry.
  • Proven ownership of GMP-relevant automation systems and validation activities.
  • Familiarity with ISA-88, CSV/CSA, change control, and CAPA processes.
  • Experience with bioprocess operations, batch execution, cleaning and sterilization.

Responsibilities

  • Own GMP-critical automation and software systems throughout their lifecycle.
  • Ensure systems are compliant, validated, secure, and fit for purpose.
  • Define requirements for electronic batch execution and recipe mgmt.
  • Lead automation projects to improve reliability, efficiency and compliance.
  • Collaborate with Operations, Quality, Validation and IT.

Skills

Automation expertise
GMP knowledge
Stakeholder management
English proficiency

Education

Bachelor/Master in Biotechnology, Biochemical Engineering, Process/Automation/Electrical/Industrial Eng or Pharmaceutical Tech

Tools

Emerson DeltaV
ISA-88 (IEC 61512-1)
DCS, recipe management, batch reporting systems
MES platforms: PAS-X, PharmaSuite

Job description

Wacker Chemie AG in Amsterdam seeks a GMP Automation & Process Engineer to ensure reliable, compliant operation of software-controlled bioprocesses in a GMP manufacturing setting. You will own automation systems, drive lifecycle management, and interface across Operations, Engineering, Quality and IT.

Ideal candidates bring 10+ years in GMP environments, deep ISA-88 and DeltaV experience, and a strong background in batch execution, validation, and process optimization.

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