Sr. Engineer R&D Mechanical Engineering

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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 o...