GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below:
Biologics Engineering Technician
- 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
Education& Key Requirements
- Relevant Trade Qualification or engineering qualification to Cert level at a minimum
- (Diploma/Degree Preferred)
- Required Minimum of 3 years in a highly regulated manufacturing (Pharma/Biologics/Medical Device) environment required.
- Proven problem solving ability on complex equipment Proven instrumentation/PLC troubleshooting ability.
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated Engineering Technician seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.