Key Role:
Technical Specialist - Engineering Operations
The Technical Specialist – Engineering Operations will be responsible for working as part of a multidisciplinary team to support the engineering function in pharma operations. The role involves building processes that meet all safety, regulatory, and organizational requirements.
Responsibilities:
* Design and process project conversations ensure reliability by design is built in prior to equipment arrival.
* Preventative and predictive maintenance for new pharma equipment being installed, including approval procedures on Maximo.
* Completion and documentation of PMs and PDMs on manufacturing equipment into Maximo.
* Ensuring commissioning spare parts are received and 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.
* Execution of protocols in a timely basis to meet the project schedule requirements.
* Review and approve process flow diagrams (PFDs), specifications, layouts, and P&IDs.
* Proactive high-performance of day-to-day preventative and demand maintenance activity to maintain manufacturing and utility equipment.
Key Skills and Qualifications:
Requirements:
* Relevant trade or engineering qualification at least minimum cert level (diploma/degree preferred).
* Minimum 3 years experience in a highly regulated manufacturing environment (pharma/biologics/medical device).
* Proven problem-solving ability on complex equipment.
* Proven instrumentation/PLC troubleshooting ability.