Biologics Engineering Technician (Shift)
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