Job description
Mission Description:
We are seeking a skilled and experienced Process Engineer to join our team. In this role, you will collaborate with the Engineering Office and Project Management to ensure the correct design, construction, commissioning, and qualification of secondary equipment and aseptic technologies packages. Your main responsibilities will include:
1. Acting as the representative for all secondary equipment-related activities and installations.
2. Supporting the Engineering Office in managing activities related to this package.
3. Maintaining regular technical contact with project stakeholders (User, QA, Validation, Maintenance, etc.).
4. Ensuring alignment between the Engineering Office and internal specifications and guidance.
5. Reviewing design and technical documentation.
6. Following up on construction and all testing activities within the package’s scope.
7. Ensuring systems start-up and resolving punch lists.
8. Writing and executing commissioning and qualification protocols/reports.
9. Providing project support in terms of technical expertise, contractor management, and troubleshooting capabilities.
10. Facilitating the handover process to the end user.
Profile Requirements:
Hard Skills:
* Deep knowledge and expertise in the design, implementation, and qualification of engineering projects within the pharmaceutical sector, specifically in secondary equipment and aseptic technologies systems.
* Ability to define functional, technical, and quality requirements.
* Experience in reviewing process studies, P&IDs, and layouts.
* Oversight of contractor performance and integration of operability and EHS requirements at all design stages.
* Preparation of project testing, commissioning, and inspection requirements.
* Organization of legal conformity visits and on-site verification of execution according to good practices.
* Coordination with supplier representatives and project stakeholders (User, QA, Validation, Maintenance, etc.).
Soft Skills:
* Strong team working and communication skills, with autonomy in managing contractors.
* Proven experience in project integration, including organization, scheduling, qualification, validation, and technologies.
* Experience in the pharmaceutical industry, particularly in high-demand EHS and cGMP environments.
Qualifications:
* Engineering degree with a minimum of 7 years of experience as a Process Engineer in secondary equipment, with a focus on aseptic filling lines and freeze-dried technologies.
* Strong experience in the pharmaceutical industry and cGMP environment.
* BA4 BT electrical certification granted by the employer.
What We Offer:
* Competitive salary and benefits package.
* Opportunities for professional development and career advancement.
* A dynamic and collaborative work environment.