Senior Validation Engineer

Senior Validation Engineer

Contract

Woburn, Massachusetts

The Senior Validation Engineer will support a diverse variety of Quality Control and Manufacturing instrumentation, including analytical and microbiological instruments, maintaining the validated state of the instruments from implementation through their full lifecycle. This role will also perform, and lead computer system validation projects related to authoring and executing specifications and validation documentation for automated laboratory systems (e.g., LIMS) per ISPE GAMP 5 guidelines.

Position Responsibilities/Essential Functions:

• Work with Operations, Quality, Technical groups, and other sites/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes.
• Responsible to author Qualification packages for a variety of Laboratory Instrumentation and Equipment. Lab equipment may include HPLCs, Chromatographers, Endotoxin Analyzers, etc., and will be subjected to Good Laboratory Practices (GLP) guidelines and principles.
• Serve as the SME for CSV presentations and maintain knowledge and information in the CSV area of expertise.
• Skilled in the use of Enterprise systems including, but not limited to site Quality Management Systems (e.g., Veeva Vault, Trackwise), Laboratory Information Management Systems (e.g., LabWare, LabVantage), and Empower and/or Chromatographic applications.
• Generate validation protocols including Computer System Validation Plan, System Requirement Specification (SRS), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM).
• Review and execute Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP guidelines, and FDA regulations.
• Liaise with manufacturing and laboratory groups in the execution of the Validation deliverables.
• Facilitate a continuous improvement culture within the Manufacturing, Engineering, and Quality Control/Assurance environments.