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Job Description

GENERAL POSITION SUMMARY:

Reporting to the GxP Facility Operations Maintenance Manager, Senior Specialist will be responsible for maintaining and documenting specific Vertex GxP facility, manufacturing and R&D lab equipment maintenance through its entire life cycle from installation through decommissioning. This hands-on position will work directly with the end users to support drug substance manufacturing operations through troubleshooting of operational issues and preventive and corrective maintenance, qualification and calibration of all assets identified as part of the equipment maintenance program. This role will be second shift.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS

• Provide technical support for troubleshooting, improving, or optimizing ongoing facilities and manufacturing operations
• Work with vendors, suppliers, and contractors to effectively execute required maintenance, calibration and qualification activities

KEY RESPONSIBILITIES:

Specific Responsibilities include:

• 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 to execute corrective and preventive maintenance
• Investigate opportunities for improvement and implement best practices
• Review/ approve vendor documentation to ensure that accurate, concise documentation is submitted and meets all the requirements of GMP's and internal SOP's
• Other duties as directed by the GxP Facility Operations Maintenance Manager

POSITION QUALIFICATIONS:

• Demonstrated hands-on experience with mechanical, plumbing, pneumatic, hydraulic, and electrical equipment and tools
• Demonstrated ability to operate independently and without direct supervision and seamlessly integrate into a team atmosphere
• Pro-active self-learner with strong troubleshooting and repair skills
• 3-5 years' experience working in a regulated industry such as pharmaceutical, nuclear, ISO, or military
• Experience with operating EMS, BMS & CMMS systems
• 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
• Excellent verbal and written communication skills
• Strong interpersonal skills including the demonstrated ability to manage through influence
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment
• Present an energetic, positive, solution-oriented attitude

PREFERRED QUALIFICATIONS:

• 3-5 years’ experience working with pharmaceutical manufacturing equipment, specifically, oral solid dosage equipment
• Current Massachusetts Journeyman Electrician License or equivalent that qualifies to perform work on related electrical components of systems after disconnect
• Understanding of FMECA and RCA and their application in an industrial environment

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