Position located in Lexington, MA

Responsibilities of the Maintenance Technician:

• Will support capital and operational projects including commissioning protocol development, overseeing FAT and SAT testing, and qualification of GxP systems.
• Equipment of ownership will include clean utilities, Process Glycol, Waste Systems and associated control systems required for new manufacturing and support areas.
• Conduct maintenance and repair of equipment, appliances.
• Communication with equipment suppliers and representatives.
• Work according to the described procedures, preparation and management of related documentation.
• Ordering spare parts for equipment/engineering systems.
• Designing of contract/engineering systems, preparation of design documents, coordination, maintenance.

Requirements of the Maintenance Technician:

• Must have 2+ years in the pharmaceutical / biotech industry supporting clean utilities.
• Plant utility experience including process glycol, plant steam, vacuum and waste systems.
• Experience with documentation requirements for GMP manufacturing facilities including Change Control and validation systems.
• Practical knowledge and application of GMP and FDA/EMA regulations, and audit support.

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