Process Engineer

DPS Group Global; Eigenbrakel; On-site; EUR 60,000 - 90,000; Full time

Job summary

DPS Group Global is seeking a Process Engineer Support for the Sterile Manufacturing Department in Belgium. You will support the Sterile Process Eng Team to implement departmental projects as a technical user representative, and provide essential GMP-compliant support across the plant.

You will coordinate project activities, draft and review documentation, train end users, and lead investigations and CAPAs while maintaining inspection readiness and strong cross-functional collaboration.

Qualifications

• Master's degree in a relevant engineering field
• Strong knowledge of GMP for sterile product development
• Experience in aseptic manufacturing and bulk filling
• Ability to manage projects in a matrixed environment

Responsibilities

• Support sterile manufacturing plant projects to deliver department strategy on time
• Provide technical support for troubleshooting and digitized processes
• Draft, review and approve cGMP documents per procedures
• Act as point of contact, trainer and coach for end users
• Coordinate project activities: URS, testing, documentation, training
• Lead deviations, investigations and CAPAs during projects
• Maintain permanent inspection readiness and GMP compliance

Skills

Project management

GMP knowledge

Safety minded

Interpersonal communication

Autonomous

Problem solving

Team collaboration

Matrixed environment

Education

Master’s degree in engineering

Job description

As a Process Engineer Support in the Sterile Manufacturing Department, you will support the Sterile Process Eng Team to implement departmental projects as technical user representative.

You will contribute by:

• Supporting projects in the sterile manufacturing plant required to deliver the department strategy and roadmap, in full scope and on time
• Providing technical support to the sterile manufacturing team for troubleshooting, equipment investigation, digitized processes, etc.
• Drafting, reviewing and/or approving cGMP documents relating to operations, in compliance with procedures and cGMP guidelines, within the framework of projects
• Being the point of contact, trainer and coach for the various end users in implementing projects (digital and/or engineering)
• Provide technical support to the production for troubleshooting, investigation, etc.
• Act in accordance with GMP compliance in all activities, ensure compliance of all business-related activities
• Maintain all activities in “Permanent Inspection Readiness” mode, contribute to achieving the Sterile Manufacturing department's compliance objectives and indicators
• Manage digital and non digital projects and/or be the department's point of contact for the implementation of projects:
  • Definition of requirements (URS)
  • Coordination all project activities to deliver on time
  • Follow-up of development & implementation steps
  • Testing for qualification/validation
  • Drafting and/or reviewing protocols/reports, procedures and documentation
  • Team training, coaching and field follow-up for the first batches

• Write and manage deviations, investigations & change controls, lead/Support technical investigations, deviations and associated CAPA in the context of the projects

Profile

• Theoretical and strong practical expertise in project management
• Master’s degree as Bioengineer, Process Engineer, Mechanical Engineer, Chemical Engineer, Industrial Pharmacist, Chemist, Biologist, or proven experience
• Strongly safety minded and knowledgeable of industry safety standards
• Good knowledge of GMP requirements for sterile product development & manufacturing
• Strong knowledge in aseptic manufacturing practices, bulk filling, aseptic filling
• Knowledge in visual inspection processes: manual, semi-automatic, as fully automatic is a plus
• Good knowledge of project management methodology
• Very good interpersonal communication skills to foster collaboration with internal customer and support departments
• Autonomous and rigorous, with an out-of-the-box approach for problem solving and an excellent team working mindset
• Ability to work in a highly matrixed and dynamic environment
• Ability to prioritize and organize daily tasks to meet deadlines, remain focused and be proactive (multitasking)
• Knowledgeable of innovative and practical solving technologies