Hiring Company: Prometheus Labs
Location: San Diego, CA
Job Type: Senior Level
Provides senior-level support for key Metrology programs, including validation and calibration.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Develop validation/qualification documents for manufacturing, laboratory and facilities equipment systems, including any associated software
• Lead cross-functional teams to establish system requirements and to apply risk management techniques to equipment system validation.
• Plan validation activities and coordinate project timelines to ensure timely and thorough completion of all validation deliverables
• Support the system validation lifecycle by performing routine system evaluations and overseeing Equipment Change Requests
• Critically review qualification, calibration and maintenance records that are submitted by other in-house personnel or by outside vendors
• When applicable, establish in-house calibration documents (i.e., Calibration SOPs, Worksheets, and Specifications) that demonstrate a controlled approach to maintaining accuracy and performance levels on complex analytical and manufacturing equipment, including automated systems
• When applicable, perform complex calibration and maintenance activities on validated systems
• Provide guidance to Equipment Owners that facilitates optimal equipment usage
o Assist Equipment Owners during selection and maintenance of equipment, helping them to choose equipment that is best-suited for their needs
o Take an active role during Equipment Operating Procedure development, helping the Equipment Owner to establish appropriate preventive maintenance practices designed to maintain a validated state and reduce equipment downtime
• Utilize equipment expertise to effectively troubleshoot system breakdowns
• Provide leadership within the Metrology department by mentoring and training less-experienced team members
• Adhere to Good Manufacturing Practices (GMPs), including adherence to all company SOPs and documentation standards
• Maintain clear, concise, and compliant records of all work performed
• Other duties as assigned.
This position has no supervisory responsibilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Generally requires a Bachelors of Science degree, with 5-8 years of related experience. Knowledge and understanding of cleanroom operations, laboratory controls and safety is required. Experience working in an FDA GXP and/or QSR regulated environment is required. Computer skills competency including Excel, Word and PowerPoint programs is required. Experience operating, calibrating, qualifying, and maintaining laboratory and manufacturing equipment is required. Experience with validating computerized equipment systems utilizing GAMP principles is required. Experience with computer systems such as BMS (e.g., Siemens Apogee) and BMQR Regulatory Asset Manager is preferred.