Process Engineer for drug-product manufacturing and packaging - September 2027

Kommlink GmbH; Lyon; Hybride; EUR 129 000 - 166 000; Temps partiel

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

MSAT experience

Process engineering

Validation

Technical transfer

GMP manufacturing

Team leadership

Communication

Independent worker

French language

English language

Formation

Bachelor's or Master in Pharmaceutical Sciences or related

Description du poste

Process Engineer for drug-product manufacturing and packaging - September 2027

• Lyon, Lyon, France/remote

For one of our clients in the pharma industry we are looking for a freelance Process Engineer for drug-product manufacturing and packaging

Project Name

Analytical Method Transfer Consultancy – Animal Vaccines

Project Description

The project encompasses the analytical transfer accompanying a strategic Animal Vaccine drug-product manufacturing and packaging transfer initiative. The objective of this assignment is the independent technical execution of analytical method transfer documentation, the structuring of technical packages, and the evaluation of compliance parameters. The goal of the project is to have documented analytical method transfers.

Tasks

Preparation of technical transfer packages

• Creation of comprehensive technical transfer frameworks to define analytical execution parameters for the receiving manufacturing site.
• Drafting of structured testing instructions for animal vaccines (including viral, bacterial, and physicochemical analyses) to establish clear product release testing parameters.
• Execution of structured technical interviews with subject matter experts to document critical process parameters and specialized methodological knowledge.
• Creation of core transfer documentation, including the identification of equipment requirements, sampling methodology, execution of technical gap analyses, and drafting of validation plans to evaluate analytical readiness.
• Compilation and structural organization of the technical package, including the integration of required procedural documents and SOPs into a consolidated master repository.

Execution of transfer compliance assessments

• Execution of technical compliance reviews to evaluate adherence to strict pharmaceutical laws, quality standards, and internal regulatory guidelines at the receiving site.
• Execution of technical specification alignments with cross-functional departments, specifically Quality Control, Engineering, and Supply Chain, to evaluate if newly transferred testing methods meet specific regulatory requirements.
• Drafting of technical progress reports detailing completed activities, flagged technical risks, and recorded major technical decisions to establish documented traceability.
• Execution of technical quality assessments on project documents to evaluate accuracy, clarity, and adherence to Good Manufacturing Practices (GMP).

Key Deliverables

Creation of comprehensive documentation with all results regarding the above-mentioned tasks with subsequent handover to client for review and approval for further usage.

Required skills, qualifications and experience

• 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.

Education

• Bachelor’s or Master’s degree in pharmaceutical sciences, biotechnology, biology, chemistry, chemical/process engineering, mechanical engineering or a comparable discipline; a doctorate is advantageous but not required.

Start

ASAP

Duration

till 30.06.2027

Capacity

25 hours/week (higher also possible)

Location

75 onsite (Lyon, France), 25% remote