Facilities/Validation & Calibration Specialist 15-WMC-03 

Wellstat Management Company, a privately-held biotech company located in Gaithersburg, MD, is seeking a Facilities/Validation & Calibration Specialist to join our team. The incumbent will provide support in this multi-faceted position in the following areas:

Overall Responsibilities:

Facilities:
  • Responsible for mechanical service calls and in-house repairs
  • Routine facility maintenance activities for all Wellstat facilities
  • Maintain building/key equipment inventories
  • This position will be required to be on-call 24/7

    Vaildation:
  • Support quality and validation programs for the Wellstat Group of Companies
  • Ensure that equipment qualifications are established and performed, process validations are completed, method validations are supported, cleaning validations are completed, and re-qualifications are tracked and performed
  • Provide monthly reports to quality management on the status of equipment qualifications / validation and equipment calibration

    Calibration:
  • Support calibration activities ensuring that the calibrations for all facility equipment are tracked and calibrated in a timely manner
  • Assurance of calibration is conducted through management of service providers and, when necessary, performing calibrations per SOPs

    Job Functions:

    Facilities:
  • Investigate, diagnose, and repair minor mechanical, electrical, plumbing, and general building problems.
  • Coordinate and schedule contractor services and provide contractor oversight.
  • Maintain and update preventative maintenance scheduling systems.
  • Ensure that preventative maintenance is completed on time.

    Validation & Calibration:
  • Draft, review and approve equipment qualification protocols.
  • Support quality validation efforts in the daily routine required for maintenance of the validation program.
  • Perform equipment qualifications and re-qualifications.
  • Coordinate validation activities with affected departments.
  • Maintain the calibration database, including maintenance of all Equipment History Files.
  • Perform routine calibrations, as required, per SOPs; coordinate and manage calibration vendors.
  • Ensure Preventative Maintenance (PM) and repairs of metrology test equipment, as well as management of validation equipment.
  • Support management of Central Monitoring System.
  • Participate in risk assessments, as required.
  • Respond to after-hours equipment alarms on-site or via remote access, as appropriate.

    Qualification/Experience:
  • Experience working in a biotechnology or pharmaceutical laboratory building, preferred
  • Experience in HVAC maintenance and repair
  • Ability to diagnose and repair minor electrical and plumbing problems
  • Experience running and/or maintaining laboratory instrumentation and/or manufacturing equipment
  • Ability to supervise contract personnel and monitor project schedules
  • Ability to work collaboratively in a cross-functional team environment
  • Must have excellent verbal and written communication skills
  • Good organizational and filing skills
  • Good working knowledge of MS Office Suite (Excel, Word)
  • Must be able to lift/carry a minimum of 40 lbs.

    Education Requirements:
  • Qualified candidates must have 5+ years in a manufacturing or mechanical environment and 3+ years in a GMP manufacturing environment. An Associate’s Degree or Technical School, preferred; relevant work experience will be considered in lieu of an advanced degree or certificate course.

    Wellstat Management Company is an equal opportunity employer and offers an excellent salary and benefits package. Send resume and salary history to: Wellstat Management Company, 930 Clopper Road, Gaithersburg, MD 20878, Attn: HR/Rich Gregorio; fax to 301/519-7005 or email to .

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