Senior Project Manager - Fill & Finish (F/M)

Location: Neuchâtel area

Start date: asap

Workload: 100%, on-site

To join our Life Sciences team in Neuchâtel, we are looking for a Senior Project Engineer Fill & Finish (F/M) .

The context:

The Project Engineer Fill & Finish must provide engineering expertise to the project for a plant revamping, from project planning and execution through to the reporting phases.

Additionally, the Project Engineer shall support the delivery of the project in interaction with the internal project team, with the selected EpCM, contractors, and equipment manufacturers.

The Project:

• Is the primary contact for the project regarding technical aspects,
• Gives input for the project treated by the Project Engineering Subteam in order to define the Detail Eng., the project schedule including the required downtime to execute the project,
• Organizes, follows up, and reviews project activities with the assigned internal and external parties, EpCM, suppliers, manufacturers, etc.
• Manages clear communication between stakeholders to achieve project objectives and project schedule,
• Drives project risk analysis to support Management in decision-making,
• Identifies financial aspects for changes of scope if any,
• Proposes corrective actions or improvements based on lessons learned from previous projects,
• Defines qualification documents in collaboration with quality engineers, Validation, QA-Val, and QA,
• Identifies required project documentation with the team, using the QRM methodology and the ASTM 2500 approach,
• Ensures permanent update of project documentation and schedule in close collaboration with the service groups,
• Supports maintenance and calibration in delivering their project activities,
• Applies engineering best practices and guidelines to define the Detail Engineering,
• Ensures implementation of divisional and corporate procedures and internal standards,
• Follows training and completes it in due time,
• Acts as the Project engineer of another EWP when his counterpart is absent.

Deliverables concerned:

• Support the Basic and Detail design, FAT, installation, commissioning/SAT, and qualification (PQ) of the assigned EWP,
• Project preparation as the technical engineering SME and representative for the project execution phases as well as the anticipated project activities/implementations during the current operation,
• Support to the EWP Lead and to the Project Engineering Lead in writing of URS, FDS, protocols for the new facility extension composed of Aseptic Filling equipment, Freeze Dryers (Lyophilisers), Isolator technology (incl VHP decontamination), CIP systems, sterile filtration, Formulation & Buffer Preparation, part washers, autoclave, stopper processor, and material preparation,
• Ensure compatibility and consistency with existing organization (site, divisional and corporate) procedures and industry standards (cGMP, GEP, SUVA/ASIT etc.),
• Define appropriate safety measures and implement them to prevent all risks of injury during the project,
• Update pre-HAZOP and HAZOP,
• Organization and coordination of working sessions with internal and external project teams as needed,
• Other project deliverables may be added during the mission.

Your Profile:

• Engineering degree in mechanical engineering, process engineering, industrial pharmacy, or equivalent.
• 5 years of experience in a similar role, preferably in the pharmaceutical or food industries.
• Expertise in aseptic filling technologies and associated regulatory standards.
• Proven ability to manage complex, multidisciplinary projects.
• Strong team management and effective communication skills.
• High analytical and problem-solving capabilities.
• Fluent in French and English.

You too can be part of the Antaes adventure!

We sincerely appreciate the interest of all applicants in our organization. However, only those selected for further consideration will be contacted.

Where applicable, the masculine form is used for readability purposes and is intended to be inclusive of all genders.

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