Description
Entreprise :
For our client, an international biotech company in Basel, we're looking for an experienced packaging engineer (primary and secondary packaging for drug products) to start latest in August. Senior professionals are welcome.
It starts with a 9 months contract, however, internalisation is intended.
Hybrid work model.
Description du poste :
The Packaging Engineer (a) will be responsible for coordination of packaging and sterilization with commercial Drug Product Contract Manufacturing organizations (CMO's), and other third-party suppliers for products as identified. Also, the Subject matter expert in the field of sterilization to oversee our CMOs running commercial sterilization processes, as well onboarding new sterilization programs and new sterilization technology.
The candidate will be responsible for the following tasks areas:
* Develops and maintains good working relationships with contract manufacturers
* Acquires and maintains scientific and technological knowledge and background of existing and new pharmaceutical (surface) sterilization technologies (VHP, EtO, NO2,..) to ensure our CMOs are aligned. Verifies CMO sterilization technologies and ensures compliance with pharmaceutical regulatory requirements (eg. Eudralex Annex 1).
* Investigates non- conformities that occurred during sterilization cycles and applies expertise to resolve these issues with the wider team at the CMO
* Coordinates periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items.
* Maintains and follows through a consolidated Manufacturing action log to ensure all manufacturing related actions are completed on time.
* Prepares Annual Product Reports with Manufacturing CMOs according to company`s needs.
* Works with CMOs and company`s participants to schedule and coordinate Steering Committee Meetings.
* Works with Quality Group and Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.
* With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
* Provides onsite process coverage as person-in-plant as needed
* Develops, collects appropriate internal and external metrics to measure CMO and company`s performance.
* Communicates manufacturing or technology related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team.
* Supervises, trains and mentors personnel as needed.
Description du profil :
The successful candidate must have:
* Bachelor degree or higher in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience
* 5-10 years of progressively responsible experience within the pharmaceutical/biotechnology industry as packaging engineer or similar
* Strong understanding is required of the biopharmaceutical packaging process
* Extensive knowledge of current Good Manufacturing Practices (cGMPs)
* Experience with product launches and product introductions
* Contract service provider experience
* Demonstrated experience with preparing/reviewing annual product review/product quality review reports
* Able to operate effectively and with a strong sense of urgency in a fast-paced environment
* Outstanding communicator: direct, effective, clear, concise, well organized and appropriate
* Experience with sterilization is a big advantage
* Business Fluency in English; German and/or French is a plus
* Domestic and International travel is required for this role