Engineer III, Validation - Process & Cleaning

About the role

As a Validation Engineer III, you will lead validation activities supporting process and cleaning validation in sterile environments, ensuring compliance, quality, and successful product launches. The role offers high visibility and cross‑functional exposure across Operations, Quality, and QC Labs, often acting as a technical lead during tech transfers and validation execution.

Responsibilities

• Write and execute validation protocols and reports for process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ).
• Conduct data analysis, deviation investigations, and reporting (approximately 70% desk‑based).
• Execute validation activities on the manufacturing floor in sterile environments (approximately 30% on‑site).
• Support tech transfers and new product introductions.
• Collaborate cross‑functionally with Operations, QC, and Quality teams.
• Participate in client interactions, audits, and regulatory readiness activities.
• Own complex validation projects and act in a project‑management capacity.
• Contribute to audits, deviations, and continuous‑improvement initiatives.

Requirements

• Bachelor’s degree.
• 4+ years of validation experience in pharmaceutical or biotech manufacturing.
• Direct experience in sterile/aseptic pharmaceutical manufacturing (e.g., aseptic filling, sterile processing, cleanroom environments) is highly preferred.

Skills

• Strong experience with process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ).
• Proven ability to write and execute validation protocols and reports.
• Familiarity with validation documentation and regulatory standards (FDA, EMA, cGMP).
• Experience with audits, audit responses, or regulatory inspections.
• Strong problem‑solving and deviation investigation skills.
• Preferred: experience in both process and cleaning validation; background in sterile filling or manufacturing operations.

Work Environment

• On‑site role in Greenville, NC.
• Monday–Friday schedule with flexibility as needed.
• Cleanroom and production‑floor exposure required.
• Adherence to Good Manufacturing Practices (GMP) and safety standards.

Benefits

• Work on cutting‑edge sterile pharmaceutical programs.
• Broad cross‑functional exposure across the site.
• High‑impact involvement in tech transfers and product launches.
• Clear path to senior and leadership roles.

Schedule

Standard (Monday‑Friday) with flexibility as needed.