Job Summary:
Performs engineering and/or metrology assignments including
instrument calibrations, equipment qualifications and process validations
involving laboratory equipment or systems; acts as equipment system subject
matter expert for client and regulatory audits; assists laboratory staff in
determining and documenting specifications for laboratory equipment; assists
with training of Associates in Engineering processes.
Performs instrument calibrations and equipment
qualifications for new and existing equipment and other metrology functions as
assigned. Manages metrology assignments
performed by outside vendors.
Drafts all pertinent equipment documents as needed
including:
Functional Requirement Specifications (FRS)
System Qualification Protocols and Reports
Process Validation Protocols and Reports
Relevant CAPA documents as needed (Nonconformances,
Corrective Actions, Preventative Actions, Effectiveness Checks, etc.)
Assists Laboratory Staff to generate User Requirement
Specifications (URS) and Equipment Operating Procedures (EOP).
Applies standard engineering techniques to improve various
processes. Works with management,
facilities technicians and laboratory technicians to contribute to completion
of process improvements.
Interact with current or potential clients and regulatory
agencies as required. Supports client
audits with respect to the equipment management system.
Coordinates work with laboratory department Management/Staff
and other support groups (i.e.: Quality Assurance, Facilities).
Assist with training of Associates on new and existing
equipment and processes.
Perform other duties as assigned by the Engineering Manager.
Recruitment for the following job codes also
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