JOB TITLE: Project Engineer Fill & Finish
START DATE: ASAP
END DATE: 28/03/2025 (with extension possibility)
LOCATION: Neuchatel, Presence on site is required for following SAT activities.
CONTEXT & RESPONSIBILITIES:
The 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 the project in interaction with the internal project team and equipment manufacturers.
Reporting to the Engineering Work Package (EWP) Lead, the Project Engineer Fill & Finish:
Is the primary contact for the project regarding technical aspects.
Gives input for the project treated by the Project Engineering Subteam to define the Detail Engineering, project schedule, and required downtime for executing the NFA project.
Organizes, follows up, and reviews project activities with assigned internal and external parties, manufacturers, etc.
Manages clear communication between stakeholders to achieve project objectives and schedule.
Drives project risk analysis to support management in decision-making.
Identifies financial aspects for changes in 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 using QRM methodology and the ASTM 2500 approach.
Ensures the permanent update of project documentation and schedule in close collaboration with 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 keeps it up to date.
Acts as the Project Engineer of another EWP when his counterpart is absent.
Routine tasks concerned:
Keep training up to date to perform all other activities mentioned.
Provide updates and feedback to the site plant engineering manager on all activities performed on a weekly basis, reducing to bi-weekly 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.
Seniority level Mid-Senior level
Employment type Contract
Job function Pharmaceutical Manufacturing
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