Fill & Finish Project Engineer – Combination Products.

For our client, a biopharmaceutical company, we are looking for a: 

Fill & Finish Project Engineer – Combination Products

Location: Canton of Valais

Contract: Permanent

Please note this vacancy requires both English and French.

Your main goal will be: 

Leading projects and serve as an expert for combination product filling, assembly and packaging processes. The role includes close work with R&D to specify design requirements for industrialization, working with QA / RA for medical/GMP QMS compliance.

Your Responsibilities: 

• Review specifications and technical design documents to provide timely and meaningful feedback in regard to fill/finish activities.

• Act as the technical subject matter expert for filling, assembly and packaging processes.

• Manage fill/finish projects for the implementation of new production lines, equipment and technology.

• Manage / participate in hazards analysis and design assessments / reviews.

• Lead end-to-end change control management in collaboration with Regulatory Affair and Quality Assurance.

• Drive innovation in fill/finish manufacturing equipment and techniques.

• Serve as the primary interface between Operations, TechOps and Quality Assurance.

• Support technology transfer, investigations, innovative technology adoption and continuous improvement.

• Provide engineering technical leadership to internal cross functional team and external development partners and component suppliers.

Your profile: 

• B.S, M.S, or advanced degree in Life Science or Engineering.

• Proven experience of leading and conducting design, qualification and technology transfer to production of commercial fill/finish line for injectable combination products. At least 5 years of experience in the pharma industry.

• Excellent knowledge of containment and Barrier systems (Isolators and RABs), pharmaceutical clean rooms and Fill & Finish of parenteral drugs (powder and liquid).

• Excellent knowledge of cGMP manufacturing environment, regulatory standards (21 CFR, ICH, etc..) and current standards for assembly, labeling, and packaging of powder, liquid and freeze-dried injectable products.

• Demonstrated success in project planning, resource management, liaison with engineering and manufacturing resources.

• Mastery of Quality tools (Six Sigma Green Belt).

• Strong skills in statistical analysis and sampling.

• Knowledge of radiation sterilization processes is a plus.

• Team spirit, ease of interaction and adaptation, ability to understand and assimilate new information, ability to synthesize, flexibility.

• Strong verbal and written communication skills in French / English.