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
client’s 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 projectsThe Maintenance Technician will serve as an integral
  member of Maintenance Operations team in a Biologics drug substance and product
  manufacturing facility.
  
• Experience ideally within the pharmaceutical or biopharmaceutical industry, or contractors working within pharma environments. Hands-on experience with CMMS (Computerized Maintenance Management Systems) essential.
  
• Strong Electrical & Instrumentation (E&I) background.Trade qualified – Solas Level 6 certification required.City & Guilds trade qualification may be considered (subject to equivalency with Solas Level 6).Experience working in BioPharma environments, including cleanroom facilities.Experience with instrument calibration activities.
  
• Exposure to utilities systems within manufacturing or pharma environments.Maintenance fitter profiles will not be considered.Ability to work onsite 5 days per week (Monday–Friday).
  
• Working hours: Monday–Thursday 8:00 AM – 4:30 PM, Friday 8:00 AM – 3:30 PM.Day role initially, with potential transition to shift work (TBC).
  

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.