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Maintenance Engineer/Technician
2 months ago
Job Title: Maintenance Engineer/Engineer
Job Summary:
Proclinical Staffing is seeking a skilled Maintenance Engineer to join our team. As a Maintenance Engineer, you will be responsible for overseeing the maintenance and repair of facilities, equipment, and utilities. This includes managing external vendors and contractors, ensuring maintenance and calibration activities are performed, documented, reviewed, and approved in the computerized maintenance management system (CMMS).
Key Responsibilities:
- Oversee utilities, facility-owned equipment, and systems, including troubleshooting equipment to determine root cause of failure modes, owning corrective and preventative actions, and associated change controls.
- Collaborate with cross-functional teams and/or lead investigations into equipment issues, including technical writing of required quality documentation.
- Oversee outside vendors and contractors to ensure work is performed and documented in compliance with cGMP policies and procedures.
- Ensure all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), safety procedures, quality standards, EH&S guidelines, and good maintenance practices.
- Promote safety within the workplace by following site safety procedures, ensuring contractors are following safety requirements, performing proactive safety assessments, and fostering a safe work culture.
Requirements:
- BSC equivalent minimum requirement in a related field.
- Proven history within the biotech pharmaceutical environment is preferred.
- Deep knowledge of Microsoft Office.
- Familiarity with Computerized Maintenance Management System (CMMS) to record maintenance work activities.
- Knowledge of cGMP documentation - Facilities documentation (work orders, equipment files, calibrations, developing SOPs) and QA systems (CAPAs, deviations, change controls).
- Excellent communication and interpersonal skills, attention to detail, flexibility, and technical writing skills.