Validation Engineer

Job Title

Validation Engineer

Job Summary

We are seeking an experienced Validation Engineer to support GMP validation activities in a pharmaceutical manufacturing environment. The ideal candidate will have strong hands‑on experience in equipment, process, cleaning, and/or computer system validation, and will work cross‑functionally with Manufacturing, Quality, Engineering, and Regulatory teams to ensure compliance with FDA and global regulatory requirements.

Key Responsibilities

• Execute and support validation lifecycle activities including URS, RA, IQ, OQ, PQ, and validation summary reports.
• Perform equipment validation for manufacturing, packaging, utilities, and laboratory systems.
• Support process validation and continued process verification (CPV).
• Execute cleaning validation studies and protocols in compliance with GMP requirements.
• Support computer system validation (CSV) activities in accordance with 21 CFR Part 11 and GAMP 5.
• Participate in change control, deviation investigations, CAPA, and risk assessments.
• Review and approve validation‑related SOPs, protocols, and reports.
• Collaborate with Manufacturing and Engineering teams during new equipment installation, upgrades, and technology transfers.
• Support regulatory inspections and audits (FDA, EMA, internal audits).
• Ensure validation activities comply with FDA, cGMP, ICH, and company quality standards.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5+ years of validation experience in the pharmaceutical industry.
• Strong hands‑on experience with GMP validation activities.
• Solid understanding of FDA regulations, including 21 CFR Parts 210, 211, and 11.
• Experience with risk‑based validation approaches (ICH Q9).
• Proficiency in validation documentation and technical writing.
• Ability to work cross‑functionally in a regulated manufacturing environment.
• Authorization to work in the USA.

Preferred Qualifications

• Experience in biologics, sterile manufacturing, or aseptic processing.
• Hands‑on experience with utilities validation (HVAC, WFI, PW, compressed gases).
• Familiarity with ICH Q8, Q9, Q10 guidelines.
• Experience supporting FDA inspections.
• Knowledge of GAMP 5 and data integrity principles.

Equipment / Systems Experience (Preferred)

• Manufacturing and packaging equipment
• Cleanroom systems and HVAC
• Utilities (WFI, PW, clean steam, compressed air)
• Laboratory instruments
• Computerized systems (MES, LIMS, SCADA, EMS)

Seniority level

Mid‑Senior level

Employment type

Contract

Job function

Science and Engineering

Industries

Pharmaceutical Manufacturing and Biotechnology Research

Location:

Clayton, NC

Salary

$ - $