Senior Validation Engineer QC and QA Laboratory Systems

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 100,000 - 140,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) seeks a Senior Validation Engineer to provide technical leadership for validation maintenance activities in QC laboratory and QA incoming systems.

You will lead protocol execution, data verification, discrepancy resolution, and lifecycle documentation to maintain validated state of laboratory equipment. Responsibilities include leading qualification for autoclaves, isolators, and controlled-temperature equipment while collaborating with QC, QA

Qualifications

• Bachelor’s degree required in engineering, science, microbiology, or related field.
• Five+ years of equipment qualification or validation experience in FDA-regulated operations.
• Experience with autoclaves, isolators, and laboratory equipment.
• Strong knowledge of cGMP documentation and validation lifecycle practices.

Responsibilities

• Lead periodic monitoring and qualification activities for laboratory autoclaves and isolators.
• Review periodic assessments for controlled-temperature chambers, laminar-flow hoods, inspection booths, and glass washers.
• Author, review, execute, and approve validation protocols, reports, assessments, and supporting documents.
• Evaluate equipment history, calibration status, deviations, CAPAs, and change controls.

Skills

Technical writing

cGMP knowledge

Validation lifecycle

Data analysis

Equipment qualification

Education

Bachelor's degree in Engineering, Science, Microbiology, or related

Tools

Kneat

CDOCs

Job description

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 who 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.

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

• Bachelor’s 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 you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

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.