Maintenance Technician

Cork - Ireland

Monthly Salary: Not Disclosed

Experience Required: 4-5years

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

About PSC Biotech

Who are we

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our clients expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

Overview:

The Maintenance Technician reports to the Manager Maintenance Operations and is responsible for executing maintenance and utility activities plant wide in a GMP compliant manner. The Maintenance Technician maintains equipment in the following areas; manufacturing operations including Upstream & Downstream processing Material Storage & Dispensing Packaging Drug Product Fill Finish Clean & Plant Utility systems WWTP and HVAC reliability programs and capital engineering projects

The Maintenance Technician will serve as an integral member of Maintenance Operations team in a Biologics drug substance and product manufacturing facility.

Requirements

Responsibilities:

Proactively maintain process utility and facility equipment in accordance with cGMP regulations applicable safety considerations Standard Operating Procedures best maintenance practices and the reliability agenda.
Maintenance and troubleshooting of equipment.
Interact with all process partners to continuously improve operations by recognising and correcting the causes of less than optimal equipment facility and team performance.
Manage external vendor support to complete required services in a GMP compliant manner.
Perform problem solving including root cause analysis as required when equipment failures result in loss of production substandard equipment performance and substantial repair cost and/or personnel safety incidents.
Ensure Electrical Process and Utility Systems are maintained in a controlled state thus ensuring compliance with all procedures and regulations and reliability initiatives.
Maintain a safe working environment by continuously promoting safety awareness recognising and rectifying unsafe conditions and performing thorough investigations when accidents occur.
Record all maintenance work performed on the site CMMS system.
Respond to critical utility alarms generated from the site automated alarm messenger system.
Maintain documentation and management and control systems in compliance with cGMP regulations and training instructions.
Where required complete and record calibrations activities completed on site and report any defects detected.
Contribute to the drive to effectively manage spares consumables and contracts in a timely and cost effective manner.
Use of permit to work system or other safety systems to control engineering activities.
Participation in HAZOP and design reviews

Education & Experience:

A relevant third level qualification in Engineering or time-served apprenticeship with 3 years Irish experience in a GMP environment preferably Bio-pharmaceuticals or equivalent industry with drug product fill finishing and packaging activities.

Scope:

This position ensures the Manufacturing Quality Control and Facilities equipment and instrumentation is maintained & operated in the calibrated state necessary to perform cGMP activities.
Maintenance Technician has scope to initiate process cost and execute continuous improvement ideas.

Required Skills:

SCOPE This position ensures the Manufacturing Quality Control and Facilities equipment and instrumentation is maintained & operated in the calibrated state necessary to perform cGMP activities. Maintenance Technician has scope to initiate process cost and execute continuous improvement ideas. EDUCATION AND EXPERIENCE A relevant third level qualification in Engineering or time-served apprenticeship with 3 years experience in a GMP environment preferably Bio-pharmaceuticals or equivalent industry with drug product fill finishing and packaging activities.

About PSC Biotech Who are we PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloud-based software soluti...