Biologics Engineering Technician

We have a current opportunity for a Biologics Engineering Technician - Ballytivnan on a contract basis. The position will be based in Sligo. 


 
Responsibilities:

• 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.

 
Requirements:

• 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

 
This role has 20% shift (days/evenings rotating on a weekly basis) - Days: 07:00 – 15:30 Monday to Thursday, 14:30 finish Friday - Evenings: 15:00 – 23:30 Monday to Thursday; 14:00 – 21:20 on Friday
 

For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.