Project engineer Fill

vor 3 Wochen

Neuenburg, Neuenburg, Schweiz Randstad Professionals Vollzeit
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 keep 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

? Definition of appropriate safety measures to prevent all risks of injury during the project

? 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 feed-back 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.

  • Fill and Finish Project Manager

    Vor 4 Tagen

    Neuenburg, Neuenburg, Schweiz Real Staffing Vollzeit

    Job DescriptionWe are seeking a highly skilled Fill and Finish Project Manager to join our team at Real Staffing. As a key member of our project team, you will be responsible for managing multiple projects simultaneously and ensuring timely completion within budget.The ideal candidate will have a strong background in pharmaceutical manufacturing and...

  • Project Coordinator for Fill and Finish Operations

    Vor 4 Tagen

    Neuenburg, Neuenburg, Schweiz Real Staffing Vollzeit

    Job OverviewWe are seeking a highly organized and detail-oriented Project Coordinator for Fill and Finish Operations to join our team at Real Staffing. As a key member of our project team, you will be responsible for coordinating multiple projects simultaneously and ensuring timely completion within budget.The ideal candidate will have a strong background in...

  • Pharmaceutical Manufacturing Engineer

    Vor 4 Tagen

    Neuenburg, Neuenburg, Schweiz Real Staffing Vollzeit

    About the RoleThis is an exciting opportunity for a Pharmaceutical Manufacturing Engineer to join our dynamic team at Real Staffing. The successful candidate will be responsible for designing and implementing processes for fill and finish operations.The ideal candidate will have a bachelor's degree in engineering or a related field and a minimum of 5 years...

  • Design Engineer Lead

    Vor 3 Tagen

    Neuenburg, Neuenburg, Schweiz EPM Scientific - Phaidon International Vollzeit

    Job DescriptionWe are seeking a highly motivated and organized R&D Engineer to fill this critical role at EPM Scientific - Phaidon International. This individual will be responsible for driving innovation, delivering results, and ensuring customer satisfaction.Main Responsibilities:Conceptualize, design, and develop new products, technologies, and...

  • Fill and Finish Process Lead

    Vor 4 Tagen

    Neuenburg, Neuenburg, Schweiz Experis Switzerland Vollzeit

    Experis Switzerland is recruiting a Fill and Finish Process Lead to support our Pharmaceutical client in Neuchatel. As a lead, you will be responsible for leading process improvement projects or activities, developing and optimizing process parameters, and ensuring process performances through Quality by Design (QbD) and Continuous Process Verification (CPV)...

  • Cloud Engineer for Capital Markets

    Vor 2 Tagen

    Neuenburg, Neuenburg, Schweiz Antaes Consulting SA Vollzeit

    At Antaes Consulting SA, we are seeking an experienced Cloud Engineer to join our team and contribute to the development of capital markets software. As an Intermediate DevOps Engineer, you will be immersed in real-life projects and have the support and guidance of an identified subject matter expert.Main Responsibilities:Design, develop, and test code using...

  • Desktop Engineer I

    Vor 3 Tagen

    Neuenburg, Neuenburg, Schweiz Stefanini, Inc Vollzeit

    We are seeking a highly skilled Desktop Engineer I to join our IT team. As a desktop engineer, you will be responsible for ensuring that our customers have access to reliable and efficient technology solutions.Key Responsibilities:Face-to-face IT support of users;Hardware installation, movement, and deinstallation;Diagnosing problems concerning personal...

  • Mixed-Signal IC Engineer

    Vor 3 Tagen

    Neuenburg, Neuenburg, Schweiz IC Resources Vollzeit

    IC Resources is seeking a highly skilled Mixed-Signal IC Engineer to join their team in Switzerland.Mixed-Signal IC EngineerThis role involves designing and developing mixed-signal ICs, leveraging expertise in analog and digital circuit design to create high-performance products.Main Responsibilities:Designing and developing mixed-signal ICs.Collaborating...

  • IT System Engineer

    Vor 2 Tagen

    Neuenburg, Neuenburg, Schweiz Formaposte Vollzeit

    LIONSCOUT, a leading talent management company with offices in Zurich and Barcelona, specializes in IT, banking, finance, and risk sectors. Our team provides personalized support and expertise to match top talent with exciting opportunities.We are working with a client, a prominent IT solutions provider, to find an IT System Engineer (Workplace-Microsoft) to...

  • Senior Engineer for Tech Transfer and Quality Assurance

    Vor 4 Tagen

    Neuenburg, Neuenburg, Schweiz BioTalent Vollzeit

    BioTalent is committed to delivering exceptional results and exceeding customer expectations. We are seeking a highly motivated and experienced MS&T Engineer to join our team in Switzerland. In this role, you will be responsible for leading complex projects and ensuring the successful introduction of new pharmaceutical products.Key ResponsibilitiesDevelop...

  • Software Engineer for Banking Systems

    Vor 2 Tagen

    Neuenburg, Neuenburg, Schweiz Antaes Consulting SA Vollzeit

    A strong IT Specialist is required to join our team at Antaes Consulting SA. As an Intermediate DevOps Engineer, you will work on various projects related to trading platforms and contribute to the development of capital markets software.Main Responsibilities:Participate in the automation of deployment solutions.Participate in environment preparation for...

  • Senior/Principal Digital IC Design Engineer

    Vor 5 Tagen

    Neuenburg, Neuenburg, Schweiz IC Resources Vollzeit

    Senior/Principal Digital IC Design Engineer A fantastic opportunity has arisen for a Senior/Principal Digital IC Design Engineer to join a dynamic team. This role offers the chance to contribute to the development of embedded MCU and DSP systems, playing a key role in shaping cutting-edge semiconductor products. If you are passionate about digital IC design...

  • Prototypes Development Engineer

    Vor 2 Tagen

    Neuenburg, Neuenburg, Schweiz Manpower SA Vollzeit

    About the Role:We are looking for a Prototypes Development Engineer to support the development of new products within our Manufacturing Development Center.You will be responsible for complex pilot processes requiring both good technical expertise and strong communication skills to collaborate effectively with the team and our partners.Key...

  • IT System Engineer

    vor 2 Wochen

    Neuenburg, Neuenburg, Schweiz LIONSCOUT GROUP Vollzeit

    LIONSCOUT specializes in talent management, with offices in Zurich and Barcelona. We focus on IT, banking, finance, and risk sectors, offering personalized support and expertise to match top talent with exciting opportunities.Are you ready for your next challenge?For our client, a leading IT solutions provider offering comprehensive IT services to public...

  • Staff Engineer

    Vor 4 Tagen

    Neuenburg, Neuenburg, Schweiz European Tech Recruit Vollzeit

    As a Staff Digital IC Design Engineer, you will play a crucial role in the development of innovative semiconductor products.Your primary responsibility will be to design, implement, and benchmark systems for various processor cores, ensuring seamless integration with product teams.This position offers opportunities for growth and professional development...

  • Life Sciences Engineer Lead

    Vor 3 Tagen

    Neuenburg, Neuenburg, Schweiz BioTalent Vollzeit

    BioTalent have teamed up with a global leader in pharmaceutical manufacturing services, and we are seeking an MS&T Engineer to join their state-of-the-art facility in Neuchâtel, Switzerland.This is your chance to work on cutting-edge projects, collaborate with cross-functional teams, and play a vital role in the development of life-changing treatments.Key...

  • HF Engineer M-F

    vor 1 Tag

    Neuenburg, Neuenburg, Schweiz Safran Trusted 4D Vollzeit

    Job Description The holder of this position will be responsible for the design of low noise electronics ranging from DC up to Ka band (radiofrequency [RF] and microwave [MW] domain). These electronics will be integrated into our future high-performance clocks or will be an update to existing products. The engineer who will be recruited, will join the...

  • Senior Engineer

    vor 3 Wochen

    Neuenburg, Neuenburg, Schweiz Gi Group SA Vollzeit

    Gi Life Sciences is looking for its partner in the Canton of Neuchâtel a:SENIOR ENGINEER (MANUFACTURING COMPLIANCE)Permanent PositionYour mission:The Senior Engineer (Manufacturing Compliance) authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging...

  • Senior Engineer

    vor 2 Wochen

    Neuenburg, Neuenburg, Schweiz Gi Group SA Vollzeit

    Gi Life Sciences is looking for its partner in the Canton of Neuchâtel a:SENIOR ENGINEER (MANUFACTURING COMPLIANCE)Permanent PositionYour mission:The Senior Engineer (Manufacturing Compliance) authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging...

  • Technical Service Engineer

    Vor 2 Tagen

    Neuenburg, Neuenburg, Schweiz Stefanini Vollzeit

    Job Overview:We are seeking a highly skilled and experienced Technical Service Engineer to join our team at Stefanini. As a key member of our IT support team, you will play a critical role in delivering exceptional customer service and technical support to our clients.Key Responsibilities:Provide face-to-face IT support to users, addressing their technical...