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Job Function:
R&D Product Development
Job Sub Function:
R&D Mechanical Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Beerse, Antwerp, Belgium
Job Description:
The Drug Product Development & Supplies is part of the Pharmaceutical Development organization and plays a crucial role in delivering medicines to our patients during the development phase of a new product. Within this organisation the Pilot Plant is responsible for the upscaling and fine tuning of formulation and processes which result in the successful clinical manufacturing of new Drug Product (DP).
For our DP pilot plant in Beerse, we are looking for a Senior Engineer.
This role will report to the Senior Manager Engineering of the Drug Product Pilot Plant – Drug Product Development & Supplies and will be based in Beerse.
Responsibilities include, but are not limited to:
As senior engineer for all Solids manufacturing equipment, you will:
* Have a full understanding of the technical aspects of the equipment and sufficient awareness of the related processes and operations
* Analyse process and project requirements and accordingly provide technical and functional recommendations
* Keep your knowledge up to date by training, peer learning, networking …
* Build relationships with suppliers and partners
* Share knowledge in the organisation: you act as the "go to" person for questions and problems
Project Management of multidisciplinary teams and accountable for the design, installation, commissioning and qualification of equipment including:
* Definition and alignment to the project scope, planning and budget
* Project team organisation
* Creation of business case and aCAR for new projects/investments
* Writing of technical specs and leading the tendering process
* Build FAT, SAT and commissioning test scripts and execute
* Supervise construction in the field
* Creation of life cycle and qualification documents (URS, Risk assessment, IOPQ, …), full qualification and deviation handling.
* Organisation and participation in assessments such as CC, SWIFT, HAZOP, FMEA, …
* Approval of qualification documents (URS, PQP, IOPQ, …), system approvals (SAP, COMET, …) and procedures (TruVault)
Qualifications
* Master's degree in Engineering or equivalent by experience
* Proven experience in Pharmaceuticals engineering with a minimum of 5 years.
* Profound knowledge of Solids equipment: feeders, blenders, spray dryers, granulators, tablet presses, … In depth knowledge of continuous manufacturing is an asset.
* Consistent track record in project management (budget, timelines & project objectives) – experience with FPX methodology or equivalent project management tools
* Full understanding of GMP in equipment design, machine directive, ATEX regulations, PED, piping standards, risk analysis methods (HAZOP, FMEA)
* Good basic knowledge of automation systems like PLC and DCS including Data Integrity aspects, user access, security settings and CFR21 part 11
* Strong communication skills
* Dutch – native or bilingual
* English – full professional proficiency
* Advanced in MS project and Microsoft Office (Excel, Word, …), know-how of TruVAULT, COMET, Summit, SAP e-stream
Role will include up to 10% of travel in function of FATs.