As a Biologics Engineering Technician with GerTEK Project Management & Technical Services, you will be working as part of a team to support engineering in pharma operations, ensuring all safety, regulatory and organizational requirements are met.
Your responsibilities will include participating in design and process project conversations to ensure reliability by design is built in prior to equipment arrival.
You will own and prepare preventative and predictive maintenance for new pharma equipment being installed, and approve these procedures on Maximo. Additionally, you will complete and document PM's and pDM's on manufacturing equipment in to Maximo.
Owning and ensuring that commissioning spare parts are received and cataloged in Maximo, as well as identifying and once received, cataloging critical spare parts in Maximo, are also key aspects of this role.
Active participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment is required.
You will review and approve process related commissioning, qualification and validation protocols for completeness and accuracy, and execute protocols in a timely basis to meet the project schedule requirements.
Review and approval of process flow diagrams (PFDs), specifications, layouts and P&ID's, as well as ensuring proactive high performance of day to day preventative and demand maintenance activity to maintain manufacturing and utility equipment, are also essential duties.
Liasing with operations, quality and technical operations to ensure equipment and process performance is maximized, maintaining records and documentation on relevant Engineering Procedures and preventative/ demand maintenance, and liaising with Internal/External Engineering Personnel and contract maintenance providers in maintaining troubleshooting, and installing/commissioning equipment, are also important responsibilities.
Completion of instrument calibration as per schedule, taking 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, and supporting the Production Team in ensuring that manufacturing equipment is maintained to meet the output and yield requirements, are all key aspects of this role.
Adhering to all relevant policies relating to Quality & Safety, ensuring successful external inspections, and Division and Corporate audits, supervision of external contractors, are also required.
To be successful in this role, you will require a relevant Trade Qualification or engineering qualification to Cert level at a minimum (Diploma/Degree Preferred) and a minimum of 5 years in a highly regulated manufacturing (Pharma/Biologics/Medical Device) environment.
A proven problem solving ability on complex equipment and instrumentation/PLC troubleshooting ability are also essential.
The work hours for this role are 20% shift (days/evenings rotating on a weekly basis) with days from 07:00 - 15:30 Monday to Thursday, 14:30 finish Friday and evenings from 15:00 - 23:30 Monday to Thursday; 14:00 - 21:20 on Friday.
This is a full-time position requiring commitment and dedication.