GerTEK Project Management & Technical Services are an outsourced technical services provider delivering worldwide contract and permanent staffing solutions. We are accepting applications for the ‘Biologics Engineering Technician’ role based in Sligo.

Major Responsibilties:

• To work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements.
• Participating in design and process project conversations to ensure reliability by design is built in prior to equipment arrival.
• Owning and preparing, preventative and predictive maintenance for new pharma equipment being installed and approval of these procedures on Maximo.
• Completion and documentation of PM’s and pDM’s on manufacturing equipment in to Maximo.
• Owning and ensuring that commissioning spare parts are received and cataloged in Maximo.
• Owning and ensuring that critical spare parts are identified and once received, cataloged in Maximo.
• Active Participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment.
• Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements
• Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s. Ensuring proactive high performance of day to day preventative and demand maintenance activity to maintain manufacturing and utility equipment.
• Liasing with operations, quality and technical operations to ensure equipment and process performance is maximized.
• To maintain records and documentation on relevant Engineering Procedures and preventative/ demand maintenance.
• To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining troubleshooting, and installing/commissioning equipment.
• Completion of instrument calibration as per schedule.
• Take ownership of the site’s Predictive Maintenance program, through managing and developing the outsourced condition monitoring contracts, implementing recommendations, and tracking to closure.
• Implementation of equipment/process upgrade in an environment of continuous improvement.
• Support the Production Team in ensuring that manufacturing equipment is maintained to meet the output and yield requirements.
• Adhering to all relevant policies relating to Quality & Safety.
• Ensure successful external inspections, and Division and Corporate audits.
• Supervision of external contractors.

Qualifications

• Relevant Trade Qualification or engineering qualification to Cert level at a minimum (Diploma/Degree Preferred)
• Minimum of 5 years in a highly regulated manufacturing (Pharma/Biologics/Medical Device) environment required
• Proven problem solving ability on complex equipment
• Proven instrumentation/PLC troubleshooting ability