Senior Pharmaceutical Facilities Specialist

Billerica, MA

Posted: 07/10/2024 Industry: Scientific Job Number: 24-00291

Job Description

Senior Pharmaceutical Facilities Specialist

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

Travel Estimate:
Up to 5%

Education and Job Qualification:
  • High school diploma or equivalent required
  • Technical certification preferred
  • 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

  • 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

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About Billerica, MA

Discover your next career opportunity in the vibrant area surrounding Billerica, Massachusetts! This bustling region offers a perfect blend of scenic beauty, historic charm, and abundant growth opportunities. From the picturesque hikes at Great Brook Farm State Park to the buzzing arts scene at The Brush Art Gallery and Studios, Billerica and its surroundings have something for everyone. Immerse yourself in the rich culture of the area, savor the local delicacies like freshly caught seafood and signature Boston cream pie, and catch a game at the iconic Fenway Park while working in this dynamic and exciting region. Explore our job listings today and take the next step towards a fulfilling career in this captivating area.