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
#LI-MS2