PE Global is currently recruiting for a Process safety Engineer for a leading multi-national Pharmaceuticals client based in Limerick City.
This is an initial 12-month contract position.
ROLE:
- Designs and specifies cGMP process equipment, piping, and controls.
- Scope and update functional Design Specifications for automation updates on process equipment.
- Manages small-to-mid sized projects related to process equipment and manufacturing. Types of equipment exposed to are as follows: WFI, CIP, Bioreactors, Centrifuges, Chromatography, Media Prep, Buffer Prep and UFDF.
- Assists in the design review, site acceptance and installation of equipment.
- Updates piping and instrumentation diagrams and other related drawings.
- Updates Process Flow Diagrams for manufacturing processes.
- Supports QA Validation department by preparation of design documents and assists in protocol execution.
- Assists in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
- Identifies & implements corrective/preventative actions (CAPAs) for existing qualified GMP equipment and manufacturing processes through site change control process.
- Identifies & implements process improvements for manufacturing processes and utilities.
- Prepares engineering evaluations and test plans for and executes change control documentation.
- May supervise mechanical, electrical, and automation contractors.
- Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
- Assists with tech transfer activities, such as process scale up and New Product Introductions.
REQUIREMENTS:
- Requires BS/BEng in Chemical, Process or Mechanical engineering with 3 + years related experience.
- Direct experience with biopharmaceutical process equipment is essential.
- Experience with compliance systems that document site change controls and corrective actions (CAPAs) e.g. Trackwise, ProcessCompliacnce, would be hugely beneficial.
- GMP and GDP experience desirable.
Interested candidates should submit an updated CV.
Please click the link to apply, call Conal on +353 21 4297900 or alternatively send an up to date CV to conal.lane@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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