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GMP Maintenance Technician
Job Title
GMP Maintenance TechnicianJob Description Summary
The GMP Maintenance Technician will be responsible for maintaining and documenting specific Vertex GxP manufacturing and R&D lab equipment through its entire life cycle from installation through decommissioning including: preventive and corrective maintenance, qualification and calibration. This hands on position will work directly with the end users and GxP Facility Operations group to maintain the traceability and accuracy of all assets identified as part of the equipment program.Job Description
- Execute corrective and preventive maintenance related to specific oral solid dosage manufacturing equipment and qualified utilities including work methods, procedures and documentation within a validated CMMS system.
- Oversee and escort non-resident contractors, and suppliers.
- Investigate opportunities for improvement and implement best practices.
- Review/ approve vendor documentation to ensure that accurate, concise documentation is submitted and meets all of the requirements of GMP’s and internal SOP’s.
- Other reporting structure, tasks and accountabilities as may be assigned by management during execution of these responsibilities.
- Ensure safe and compliant daily maintenance and operation of the clinical materials production facility and equipment
- Point of contact to resolve equipment and facility issues to keep the production facility running and in compliance (process equipment, janitorial, mechanical systems, Environmental Monitoring, USP RODI water, process gases, controlled access, Building Management System, etc.)
- Work within the engineering document control system. Write, review, and approve facilities/utilities/equipment/instrument SOPs, policies, workflows, training documents, etc., including Environmental, Health Safety (EHS) procedures in area of responsibility
- Rotation on call for facility emergencies
Required qualifications:
- 3-5 years experience working with pharmaceutical manufacturing equipment
- Hands-on experience with electrical, mechanical, plumbing, pneumatic, hydraulic and mechanical equipment and tools.
- Experience with operating equipment control systems (BMS, SCADA, etc.)
- Experienced working with a CMMS systems – Maximo experience is a plus.
- Physical abilities include but not limited to, lifting objects up to 50lbs, able to be on feet all day, climb steps and ladders as required by job.
- Experience working in regulated environment, specifically in Biotechnology, Pharmaceuticals, or Research and Development (R&D)
- Possess the ability to describe in detail, and with appropriate confidence, position’s role in the maintenance program.
Preferred Qualifications:
- Present an energetic, positive, “can do” attitude
- Excellent verbal and written communication skills
- Strong interpersonal skills including the demonstrated ability to manage through influence.
- Effective communication skills, both verbal and written
- Ability to navigate and be successful in a fast-paced work environment
In compliance with the Americans with Disabilities Act Amendments Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a position at Cushman & Wakefield, please call the ADA line at 1-888-365-5406 or email HRServices@cushwake.com. Please refer to the job title and job location when you contact us.
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