Senior Validation Engineer QC and QA Laboratory Systems

Validation & Engineering Group Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.

We are seeking a Senior Validation Engineer will provide technical leadership for validation maintenance activities involving QC laboratory and QA incoming systems. The position will lead periodic monitoring equipment periodic review protocol execution data verification discrepancy resolution and lifecycle documentation necessary to maintain the validated state of laboratory equipment.

• Senior Validation Engineer QC and QA Laboratory Systems

Key Responsibilities

• Lead periodic monitoring and qualification activities for laboratory autoclaves and isolators.
• Lead or review periodic assessments for:
  • Controlled-temperature chambers.
  • SO 5 laminar-flow hoods.
  • Inspection booths.
  • Glass washers.
  • Other QC and QA laboratory equipment within the approved scope.
• Author review execute and obtain approval of validation protocols reports assessments and supporting documents.
• Evaluate equipment history calibration status preventive maintenance deviations CAPAs change controls alarms failures and operational performance.
• Determine whether equipment remains in a validated state and document the technical rationale.
• Develop test strategies acceptance criteria data sheets sampling plans and discrepancy-resolution approaches.
• Review raw data and perform or oversee independent data verification.
• Coordinate thermocouple placement temperature-mapping equipment wireless data loggers and other calibrated instruments.
• Investigate failed or invalid runs and support root-cause analysis and corrective actions.
• Participate in validation assessments associated with change controls deviations capital projects non-capital projects and business-case evaluations.
• Manage document workflows and review comments in Kneat CDOCs or applicable systems.
• Provide technical support during regulatory audits inspection interviews pressure tests and validated-state presentations.
• Coordinate execution with QC laboratories QA Incoming Maintenance Metrology Engineering and other stakeholders. Support execution outside normal administrative hours when required.

Qualifications

• Bachelors degree in Engineering Science Microbiology or a related field.
• Five or more years of equipment qualification or validation experience in pharmaceutical biotechnology or other FDA-regulated operations.
• Direct experience with autoclaves isolators controlled-temperature equipment laboratory hoods glass washers or comparable laboratory systems.
• Experience with thermal mapping temperature sensors data loggers calibration documentation and qualification data analysis.
• Strong knowledge of cGMP documentation validation lifecycle practices deviations CAPAs and change control.
• Experience authoring and executing protocols and reports in Kneat CDOCs or comparable electronic validation systems.
• Strong technical writing skills in English.

At Validation & Engineering Group people always come first. We believe that when youre empowered to do your best work bold ideas thrive and real progress happens. This isnt just a job - its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven supportive team.

Excited to build something meaningful together We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status.