Validation Specialist – QC Equipment (CSV Focus)

Technical & Engineering Consulting • Yauco, PR

1d

About The Position

Technical & Engineering Consulting is seeking a Validation Specialist with strong Computer System Validation (CSV) experience to support Quality Control (QC) laboratory equipment qualification in a regulated pharmaceutical environment. This role will focus on analytical laboratory systems, including FTIR Spectrophotometers (Identification testing) and Endotoxin testing systems (e.g., Nebula), ensuring compliance with cGMP, Data Integrity, and regulatory expectations.

Requirements

• Bachelor’s degree in Microbiology, Chemistry, Engineering, or related field
• 3–5 years of experience in validation within regulated environments (Pharma / Biotech / Medical Devices)
• Hands-on experience with QC laboratory equipment qualification
• Strong knowledge of Computer System Validation (CSV)
• Experience with analytical instrumentation (e.g., FTIR, endotoxin systems)
• Familiarity with: cGMP regulations
• Familiarity with Data Integrity (ALCOA+)
• Familiarity with Validation lifecycle documentation

Nice To Haves

• Experience with FTIR Spectrophotometer (ID testing)
• Experience with Endotoxin testing systems (Nebula or similar)
• Knowledge of LIMS, Empower, or other lab systems
• Experience with TrackWise, Kneat, or similar validation systems
• Familiarity with GAMP 5 methodology

Responsibilities

• Execute qualification and validation activities for QC laboratory equipment and computerized systems
• Develop and/or support protocol generation (IQ, OQ, PQ)
• Perform protocol execution and discrepancy resolution
• Support review and approval of validation documentation
• Ensure compliance with CSV lifecycle requirements (GAMP 5 approach preferred)
• Utilize electronic document management systems (EDMS) for documentation control
• Support data integrity assessments and audit readiness
• Collaborate with QC, QA, IT, and Validation teams
• Ensure alignment with QC lab requirements and regulatory standards (FDA, cGMP)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level