Equipment & Technology Engineer for large pharmaceutical client
PM Group is a specialist international engineering, architecture and project management company. Headquartered in Ireland, we employ over 1,800 people at our offices in Dublin, Cork, the UK, Poland, Prague, Russia, Singapore, Shanghai and the US.
Job Title: Equipment and Technology Engineer
We have an immediate requirement for an Equipment and Technology Engineer on contract for large pharmaceutical client. The role will be based in Dublin
Role and Responsibilities:
- Lead all aspects of the design development, installation, commissioning, qualification and start-up of bespoke filling & packaging equipment & technology for diverse portfolio.
- Design development, installation, commissioning, qualification and start-up of manufacturing equipment and technologies for commercial production
- Support the Global Engineering & local design team in the development of all technology & equipment engineering industrialisation programs in support Global Engineering capital program
- SME in the design development, installation, commissioning, qualification and start-up of bespoke equipment in the respiratory or device arena that meet product performance and quality requirements.
- Manage key technology & equipment vendor relationships with responsibility for associated project & budget management against work-plans and cost reduction initiatives
- Support of all product and process technology development, and its qualification and transfer to production
- Manage all cGMP documentation requirements for relevant technology & equipment
- Equipment & technology subject matter expert supporting design and process risk assessments internally and at vendors
- Manage all PDI , FAT , SAT , Qualification and site start up activities for relevant technology & equipment
- Troubleshooting of manufacturing equipment & technology issues as they occur in respiratory clinical supply and commercial manufacturing facilities
- Point of accountability with internal and external partner groups/project teams on all equipment development & industrialisation programs to ensure they fully integrate with and achieve required timelines for overall project delivery
- Responsible for management of budget with external suppliers, ensuring proactive budget forecasting, invoicing processes against work-plans, and cost management and reduction initiatives
- Support design, product and process technology issues during development, qualification and transfer to production of new process technologies
Qualifications and Experience
- Degree in mechanical/industrial engineering or equivalent or significant relevant experience
- 7 years+ experience in a pharmaceutical engineering environment
- Strong filling & packaging equipment background, with experience from the clinical phase through to commercial requirements
- SME in the design development, installation, commissioning, qualification & start-up of bespoke equipment.
- Proficient in manufacturing risk analyses techniques (e.g. FMEA) and their application in manufacturing and equipment development processes
- Experience in managing complex design programs with external parties
- Experience in successfully and proactively managing large budgets with external suppliers
- Experience working in the pharmaceutical industry in the development of devices for drug delivery
- Willingness to regularly travel globally as required
- Contract role based in Dublin
All CV’s are treated in the strictest confidence
RECRUITMENT AGENCIES NEED NOT APPLY