Stallergenes Greer

Technical Services Manager

Job Description

Essential Duties and Responsibilities include:

  • Work with support departments to obtain user requirements for equipment/utilities, assist in the vendor review, instrument demonstrations/evaluations and final vendor selection process.
  • Develope and maintain a Comprehensive Validation Master Plan including, but not limited to facilities, process equipment, and associated software and hardware.
  • Implement and/or assist in the development of documentation, including calibration and validation related procedures/forms/specifications (equipment, process, method, software, etc.)
  • Implement and/or assist in the development of documentation for operation, maintenance and cleaning of equipment (i.e. Equipment Operating Procedures)
  • Oversee the generation, execution, development, and maintenance of Validation Protocols, IQ/OQ/PQ and Final Reports associated with equipment, systems and processes.
  • Provide validatin and metrology expertise in regulatory (FDA, ISO, CAP, CLIA) audits, as well as internal and client audits.
  • Participate in the selection and qualification of new equipment, systems and processes, providing critical input from a validation perspective.
  • May negotiate and manage multiple contracts with outside vendors performing calibrations maintenance, and/or validation activities.
  • Oversee the execution of various Preventive Maintenance activities on common laboratory and manufacturing equipment.
  • Provide technical support to Project Teams by defining how applicable equipment and support utilities are controlled/tested/qualified.
  • Ensure equipment exceptions (e.g., Out of Tolerances) and changes are appropriately documented, investigated, and/or tested.
  • Maintain a current status/schedule of laboratory equipment as it relates to calibration and validation status

Education Requirement

Bachelor's Degree in a scientific field required

 

Experience Requirement

7+ years of direct pharmaceutical experience required.

Previous experience with calibration/validation of facilities and equipment

Experience with cleanrooms, equipment data bases and Building Management systems is required.

Additional Skills

To apply for this position, please visit your local Employment Security Commission office. You may also direct questions to .(JavaScript must be enabled to view this email address).

 

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