Senior Technical Operations Validation Specialist

Jackson Healthcare-posted 2 months ago
Senior
Bristol, TN
1,001-5,000 employees
Administrative and Support Services
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The Senior Technical Operations Validation Specialist is the subject matter expert (SME) for various types of technical responsibilities which are within the scope and oversight of the pharmaceutical quality unit, encompassing validation of processes, equipment, facilities, cleaning procedures, and computerized systems; commercial support, and research and development support as needed. Establishes that all computerized systems are functioning as intended and designed. Ensures that all written procedures and practices are in place for computerized systems and serves as primary support for QC and Technical Support laboratories for analytical method development, problem solving and validation in addition to leading equipment validation.

  • Create validation protocols for processes, equipment (IQ, OQ, and PQ), cleaning procedures, facilities, and computerized systems.
  • Serve as system administrator and technical SME responsible for ensuring systems are qualified and functioning as intended.
  • Provide primary technical support for QC laboratories for analytical method development, problem-solving, and validation.
  • Configure and test software such as Quality Control Laboratory Information Management System (LIMS) and Chromatography Data System (CDS).
  • Prepare and compile data to analyze test information to determine process or equipment operating efficiency.
  • Study chemical compounds and use research to support the development of products or processes.
  • Support risk assessments for any product quality inquiries and emerging risks.
  • Liaise with laboratory section managers and other QC personnel to support questions and resolve problems.
  • Support technical documentation for CMC supplements, Annual Reports, and Annual Product Reviews.
  • Assist with evaluation and implementation and validation of identified software for new applications.
  • Notify lab personnel of any operational challenges or hardware/software system failures.
  • Set up/modify product specifications, test methods, calculations per methods, and perform test runs in LIMS and SAP.
  • Recommend improvements to methods and operations for cGMP compliance and efficiency.
  • Assist with technical writing, including revision of analytical procedures and SOPs.
  • Carry out other departmental duties as deemed appropriate by Manager.
  • Keep current with technical and professional literature and attend training opportunities.
  • Encourage safety first in work practices.
  • Perform statistical analysis of laboratory and process data.
  • Technical writing skills, including validation protocols, risk assessments, and SOPs in a FDA-regulated environment.
  • Problem-solving skills.
  • Ability to perform independent research for scientific and technical justification.
  • Data analysis skills, including statistical analysis of process and laboratory data.
  • Strong computer skills, including word processing, spreadsheets, and application software.
  • Experience with SAP and related laboratory software.
  • Knowledge of analytical methodologies and instrumentation.
  • Experience in a multi-disciplinary team environment.
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