ProStaff Workforce Solutions is seeking a Senior Plant Services Specialist for one of the largest pharmaceutical companies in Billerica, MA. Our client is one of the leading pharmaceutical companies in the region and specializes in the production and sale of radiopharmaceuticals and formulation, analytical methods development and production of parenteral drugs. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.

Direct Hire

Job Summary:
Support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMP) and Good Documentation Practices (cGDP) requirements.

Area Of Responsibility:

Develop and maintain electronic and paper records on pharmaceutical manufacturing equipment, utilities, and systems to maintain operations and validation
Operate production equipment (Isolators filling line, Lyophilizer, powder filling) for setup and or production purposes as needed
Manage execution of PMP programs consistent with cGMP engineering maintenance requirements
Interact with and direct vendors for manufacturing improvement and plant maintenance (i.e. HVAC, Clean Utilities, trades) primary support for Security/System Monitoring/Fire System, janitorial services, and waste water certifications
Perform non-routine and off-hours tasks as necessary
Support area validation, calibration, certification efforts, and the transfer of new processes to the manufacturing area
Perform equipment, utility, and plant validation as needed
Review and update maintenance SOPs for plant, equipment, and utilities
Follow all company policies related to job safety
Work independently with minimal supervision using some standard procedures as well as troubleshooting and decision making
Troubleshoot complex manufacturing equipment/plant/utility problems
Support operations improvement and maintenance projects
Perform improvements and maintenance as required to support all operations
Support validation maintenance program
Execute validations for manufacturing equipment and processes as needed
Maintain and review records for operations plant, equipment, and utilities
Monitor steam utility per MA State requirements
Maintain records for waste water requirements
Manage janitorial services and plant waste stream
Support in the development and mentor of peers
Monitor process operations to ensure compliance with specification
Ensure equipment operational readiness
Subject matter expert for multiple processing technologies (vacuum pumps, chilled water systems, autoclaves, WFI, Clean Steam)
Other duties as assigned

Work Conditions:

Office
Lab
Shop/shipping areas
Some exposure to noise, hot and cold, outside elements, radiation exposure within allowable limits

Physical Requirements:

Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste, smell
Close, distance and peripheral vision; depth perception, ability to focus
Ability to operate production equipment and hand tools
Operate hand truck
Operate company truck
Current, valid Driver's license
Operate computer/office machines
Wear Safety shoes, safety glasses, gloves
Lift up to 70 lbs.
Ability to work a flexible schedule

Travel Estimate:
Up to 5%

Qualifications:

High school diploma or equivalent required
Technical certification preferred

Minimum 3-5 years related experience
Experience working with process equipment (compounding, vial washing, vial filling, ampoule and powder filling)
Experience working with electronic document systems (CMMS work orders, LMS, Track Wise, Master Control) or similar systems

Experience with Building Automation Systems
HAZMAT training
Formal cGMP training
Proficient with use of hand tools and power equipment
WFI water system experiences a plus

Knowledge of pharmaceutical Plant/Maintenance/manufacturing Operations or related environment
Knowledge of aseptic techniques
Ability to read & create engineering drawings
State boilers “Special License to Operate” or higher preferred / obtain within 6 months of employment
Electrician’s license preferred
Ability to plan, prioritize and organize diversified workload
Familiarity with use of computers and MS Office

Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.

Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.

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