Maintenance Engineer
At our biotech manufacturing facility, we are seeking a skilled Maintenance Engineer to play a key role in ensuring the optimal functioning of plant items, utilities, and machinery.
Key Responsibilities:
* Perform technical operation and maintenance of plant items, utilities, and machinery to ensure compliance with GMP and regulatory requirements.
* Maintain validated state of GMP equipment.
* Install, perform emergency, corrective, and preventive maintenance (PM) of equipment under direct or minimal guidance.
* Conduct routine PMs and related paperwork according to scheduled timelines and eMaint (CMMS) updates.
* Coordinate and manage maintenance contractors/equipment vendors on site, issue permits to work.
* Review reports and records.
* Provide engineering expertise for troubleshooting issues and finding solutions promptly.
Additional Responsibilities:
* Analyze breakdowns using root cause analysis and problem-solving tools.
* Work closely with project teams to assist in specification, installation, commissioning, and testing of new or recommissioned equipment/plant/utilities.
* Attend factory acceptance tests (FATs) to ensure adherence to user requirements specifications and associated requirements.
* Provide engineering input to deviations, corrective actions, and change controls.
* Participate in internal audits.
* Manage supplies and spare parts inventory.
* Contribute to projects improving system performance and reliability.
Requirements:
* Bachelor's degree or equivalent trade qualification in an engineering discipline.
* 5+ years of industry experience in a GMP manufacturer.
* At least 3 years of experience in maintaining chemical, HVAC/mechanical systems, pneumatic & hydraulic systems, electrical power systems, control systems, building management systems.
* Experience in maintaining utilities, facilities & production/process equipment.
* Strong technical aptitude.
Proficient in MS packages and experience working with CMMS, AutoCAD, and ability to read & interpret technical drawings & specifications are required. Experience with utilities, pharmaceutical areas, tablet manufacturing, and equipment validation is advantageous.