Automation Engineer / Ingenieur

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Job description:

We are looking for an Automation Engineer to support documentation and change control processes within a regulated GMP environment. The role focuses on managing technical project documentation across design, execution, and qualification phases, ensuring compliance and coordination between internal teams and external partners.

About the customer:

Duration: ASAP - 12 months with potential extension
Workload: 100% (two positions)
Language: English (business fluent), German a plus
Environment: cGMP/GxP manufacturing, automation projects (tech transfers, new technology introductions)

Requirements:

Manage the lifecycle of technical project documents (URS, FDS, P&IDs, vendor documentation).
Ensure compliance with GMP standards and documentation requirements.
Coordinate review and approval workflows in electronic document management systems (EDMS).
Act as an interface between engineering, QA, validation, production, and external partners.
Support GMP change documentation (CRs/TCRs) and ensure full traceability.

Competences:

Degree in Engineering, Life Sciences, or related field.
3+ years of experience in a regulated GMP environment (pharma/biotech preferred).
Experience with technical documentation and EDMS tools.
Strong organizational and coordination skills.
Fluency in English; German is an advantage.

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