Project engineer Fill
Vor 4 Tagen
Job Description
START DATE: ASAP
END DATE: 28/03/2025 (with extension possibility)
LOCATION: Neuchatel, Presence on site is required for following SAT activities.
CONTEXT & RESPONSIBILITIES:
Project Engineer Fill & Finish must supply engineering expertise to the project of the new plant extension at the Neuchâtel site, namely NFA project, from project planning and execution till reporting phases.
Additionally, the Project Engineer shall support the delivery of project in interaction with the internal project team, with the equipment manufacturers.
Reporting to the Engineering Work Package (EWP) Lead, the Project Engineer Fill & Finish:
- Is 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 incl. the required downtime to execute the project NFA
- Organizes, follows up and reviews project activities to the assigned internal and external parties, manufacturers, etc.
- Is managing clear communication between stakeholders to achieve project objectives and project schedule
- Drives project risk analysis to support to the Management to take decisions
- Does identify financial aspects for the changes of scope if any
- Is proposing corrective actions or improvements based on the lessons learnt of previous projects
- Defines qualification documents in collaboration with quality engineers, Validation, QA-Val and QA
- Does identify 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 the engineering best practices and guidelines to define the Detail Engineering
- Ensures implementation of divisional and corporate procedures and internal standards
- Follows training and keeps them done in due time
- Acts as the Project engineer of another EWP when his counterpart is absent
Deliverables concerned:
- NFA as a Project Engineer Fill & Finish as well as the tasks owner for elements of the general program. Support the commissioning/SAT and qualification (PQ) of the assigned EWP
- Project preparation as the technical engineering SME and representative for NFA 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 protocols/reports for the new facility extension composed by 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 HAZOP
- Organization and coordination of working sessions with internal and external project teams as needed
- Other project deliverables may be added during the mission.
Routine tasks concerned:
- Keep his/her Training up to date to be allowed to perform all the other activities mentioned in this list.
Management session to provide updates and feedback to the site plant engineering manager on all the activities performed on a weekly basis at the beginning. Should be brought down to once every two weeks after the first two months.
Requirements
Education:
- Bachelor's or Master's degree in Engineering (Mechanical, Chemical, or similar) or related technical field.
Experience:
- Minimum 3-5 years of experience as a Project Engineer, ideally in Fill & Finish or pharmaceutical/biotech industries.
- Proven experience with aseptic filling equipment, lyophilizers, isolator technologies (including VHP decontamination), CIP/SIP systems, and sterile filtration processes.
- Strong understanding of cGMP, GEP, and regulatory compliance standards (e.g., FDA, EMA).
- Experience with project planning, commissioning/SAT, and qualification (DQ, IQ, OQ, PQ).
Technical Skills:
- Knowledge of risk management tools (e.g., QRM methodology, ASTM 2500).
- Ability to write and review qualification protocols, reports, and technical documentation.
- Familiarity with safety standards (e.g., SUVA/ASIT) and HAZOP updates.
- Proficiency in project management tools and methodologies.
Languages:
- Fluency in French and English (written and spoken) is required.
Soft Skills:
- Excellent communication and stakeholder management skills.
- Strong problem-solving and decision-making abilities.
- Ability to work in a multidisciplinary and multicultural team.
- Organizational skills with attention to detail and deadlines.
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