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Valspec

Computer system validation and lifecycle services

Lead Validation Engineer

Regulatory & Quality (Life Sciences)Posted on Nov 10
Full-timeCalifornia, USANo salary listed

About the Job

Requirements

  • A bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical field is required.
  • Strong validation experience within pharmaceutical, biotechnology, or other GxP-regulated manufacturing environments is required.
  • Experience leading Computer System Validation or automation validation projects is required.
  • Hands-on experience with IQ/OQ/PQ, risk assessments, requirements, traceability, deviations, and validation reporting is required.
  • Experience validating SCADA, PLC, Environmental Monitoring, historian, database, or manufacturing control systems is required.
  • A strong understanding of GxP, data integrity, audit trails, electronic records, and risk-based validation is required.
  • The ability to work on-site in Southern California is required.

Responsibilities

  • Lead validation activities for SCADA, PLC, and Environmental Monitoring System upgrades.
  • Develop and execute validation documentation, including Validation Plans, user requirements specifications, risk assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
  • Lead qualification of control systems, virtual infrastructure, servers, SQL databases, historian interfaces, and operator workstations.
  • Develop and execute risk-based testing for alarms, audit trails, user access, data integrity, backup and recovery, and system interfaces.
  • Support data migration, user acceptance testing, performance qualification, discrepancy resolution, and system release.
  • Coordinate validation activities across Quality, Automation, Engineering, IT, Operations, and external vendors.
  • Maintain project schedules and communicate validation status, risks, and issues to project leadership.

Desired Qualifications

  • Experience with GE Digital iFIX or similar SCADA platforms is preferred.
  • Experience with Rockwell PLCs and industrial control systems is preferred.
  • Experience with VMware, Windows Server, and SQL Server is preferred.
  • Experience with process historians and data migration is preferred.
  • Experience with Kneat or similar electronic validation systems is preferred.
  • Previous experience leading complex automation or computerized system validation projects is preferred.

About the Company

Valspec

Computer system validation and lifecycle services

Valspec provides validation, testing and qualification services for manufacturing automation and IT systems used in making drugs. It covers the full system life cycle, from commissioning to qualification and ongoing validation, ensuring computer systems and manufacturing equipment perform correctly and compliantly. Its offerings help life sciences companies meet regulatory and quality goals, optimize production and support development of therapies. Valspec differentiates itself by deep plant automation and engineering expertise, a track record of supporting projects that bring life-changing drugs to market and improve production efficiency, and a focus on pairing passionate engineers with projects that require rigorous validation and lifecycle services. The company’s goal is to help clients deliver reliable, compliant manufacturing systems and therapies to patients while enabling cost-effective production and faster access to medicines.

Company size
51-200
Company stage
Not listed
Total funding
Not listed
Headquarters
Royersford, PA
Founded
Not listed

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