Lab C&Q Engineer

Summary:
A global biopharmaceutical company based in Cork is looking for a Laboratory C&Q Engineer who will be working as part of a Laboratory team. Previous laboratory experience in the Pharmaceutical/ Biotechnology industry is essential.

Responsibilities:

• Lead C&Q asset delivery for assigned projects through planning, scheduling, execution and handover.
• Coordinate new instrument IOQ’s and instrument down time for system upgrades, operating system upgrades and requalification’s, liaising with SME’s, C&Q, Automation and Computer Systems Validation.
• Coordinate new instrument commissioning and instrument downtime for system upgrades, operating system upgrades for laboratories
• System User Requirements, Design Qualifications.
• C&Q Risk Assessments, P&ID scoping.
• Vendor & Contractor coordination and supervision (offsite and onsite).
• Review and acceptance of contractor and vendor handover documentation.
• Manufacturing Evaluation Forms.
• Acceptance of systems at Mechanical Completion.
• Project Change Control and Discrepancy Management.
• To liaise with internal/external laboratory and engineering personnel, contract maintenance providers and vendors in identifying lab instruments that need replacing.
• To ensure completion of installation and validation of new and upgraded test instruments and to maintain record and documentation on relevant procedures.
• Assist in the management of vendors and work directly with them on new projects.
• Maintaining a current working knowledge with regards to regulatory requirements for equipment qualification and calibration.
• Set up of Regular Maintenance program for Lab Instruments on CMMS and coordinate with lab and vendor to schedule maintenance.
• Ability to manage workload of multiple projects of varying complexity.
• All aspects of Health & Safety on site.Qualifications & Experience:
• B.Eng. degree in Science is preferred along with 3 to 5 plus years’ experience in Analytical/ Micro/ Quality Lab environment in Pharmaceutical/ Biotechnology industry.
• Candidate must have proficiency in a windows based environment and software (Word, PowerPoint, project, advanced excel and access).