Our client, a leading biopharmaceutical company, is keen to hire a Process Equipment Engineer to join their team in Sligo on a 12-month contract.
Responsibilities of a Process Equipment Engineer (Full description available upon request):
To work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements.
Process and equipment engineering Subject Matter Expert for a vial filling and isolator equipment from design phase to equipment handover.
Review, and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.
Review vendor design documentation to ensure compliance with process and technical specifications.
Lead the FAT and SAT activities ensuring the equipment is design, fabricated and tested to meet the technical requirements of the project.
Support foller equipment installation integration and co-ordinate vendor supervision as required.
Support the development of the project commissioning and validation plan.
Review all process related validation protocols for completeness and accuracy.
Understands the impact of equipment control systems on processing performance Investigate process exceptions or equipment malfunction incidents affecting the process.
Ensure successful external inspections, and Division and Corporate audits.
Ideal Background:
A relevant third level qualification in an engineering, science or technical discipline (Degree Level or master’s Preferable)
At least six (5) years of total combined experience in Process / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.
At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, and sterilization operations preferable.
Experience in new product introductions (drug product) to pharmaceutical facilities is desirable.
For a confidential discussion and more information on this Process Equipment Engineer role, please contact Sarah Flynn.
sarah.flynn@collinsmcnicholas.ie
+353 719108060