MSAT Process Engineer — Drug-Product Transfer (Remote)

Kommlink GmbH

Lyon

Hybrid

EUR 129,000 - 166,000

Part time

14 days+

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Job summary

Kommlink GmbH in Lyon, France seeks a freelance Process Engineer for drug-product manufacturing and packaging with 25% remote work. The project covers analytical method transfer consultancy for Animal Vaccines, aiming for independent technical execution and documented transfers.

Responsibilities include preparing technical transfer packages, drafting testing instructions for analytical assays, interviewing SMEs, compiling the master documentation, and conducting GMP-compliant transfer

Qualifications

5–10 years of relevant professional experience in MSAT, process engineering, validation, technical transfer or GMP manufacturing.
Experience in process or technology transfer and technical/GMP document authoring.
Experience leading teams or workstreams in a matrix organization.
Professional and convincing communication with internal and external international stakeholders.
Ability to work independently, autonomously and collaboratively in a project team.
Strong knowledge of sterile drug-product manufacturing and relevant technologies, especially filling and freeze-drying, with working knowledge of visual inspection and packaging.
Knowledge of the pharmaceutical product lifecycle and the interfaces between development, technical transfer, validation, regulatory submission and commercial supply.
Ability to evaluate process data, equipment and facility fit, manufacturing history, deviations, CAPAs, process risks and validation evidence.
Knowledge of transfer-document preparation, GMP technical writing and regulatory-document contribution.
Sound project-management knowledge, including work-package planning, prioritization, action tracking, risk management and concise reporting.
Language requirements: French and English.

Responsibilities

Prepare technical transfer packages for analytical method transfer.
Draft structured testing instructions for analyses (viral, bacterial, physicochemical).
Conduct structured SME interviews to document critical parameters.
Create core transfer documentation and master repository.
Perform technical compliance reviews against GMP and regulatory guidelines.
Align specifications with QC, Engineering and Supply Chain.
Draft technical progress reports with risks and decisions.
Assess project documents for accuracy and GMP compliance.