Engineer III, Validation - Process & Cleaning

Description

The company develops life-changing therapies through sterile pharmaceutical manufacturing.

As a Validation Engineer III, you lead process and cleaning validation in sterile areas, helping the site stay compliant, meet quality standards and launch products on time.

The role spans Operations, Quality and QC Labs, and you often act as technical lead on tech transfers and validation runs.

Responsibilities

• Lead process validation and cleaning validation work in sterile areas.
• Qualify equipment through IQ, OQ and PQ stages.
• Support tech transfers and the introduction of new products.
• Work with Operations, QC and Quality colleagues across projects.
• Take part in client meetings, audits and regulatory readiness work.
• Own complex validation projects and, where needed, manage them as a project.
• Contribute to audits, deviation handling and continuous improvement.

Requirements

• You have strong experience in process validation, cleaning validation and IQ/OQ/PQ equipment qualification.
• You can write and carry out validation protocols and reports.
• You know validation documentation and regulatory standards.
• You have been exposed to audits, responses to audit findings or regulatory inspections.
• You solve problems well and investigate deviations thoroughly.
• You hold a bachelor's degree and have 4+ years of validation experience.
• Experience in pharmaceutical or biotech manufacturing is required.
• Cleanroom and production floor exposure is required.
• Preferred: experience in both process and cleaning validation.
• Preferred: background in sterile filling or manufacturing operations.
• Preferred: knowledge of FDA, EMA and cGMP regulations.
• Highly preferred: direct experience in sterile or aseptic pharmaceutical manufacturing, such as aseptic filling, sterile processing or cleanroom environments.

Conditions

Standard Monday to Friday schedule, with flexibility when needed.

Onsite role in Greenville, NC.

Follow all GMP safety standards in both office and floor settings.

About 70% of your time is desk work: protocols, data analysis, deviation investigations and reporting.

About 30% of your time is on the floor, running validation in sterile manufacturing environments.

Benefits

• Work on newer sterile pharmaceutical programs.
• Build broad cross-functional experience across the site.
• Join high-impact tech transfers and product launches.
• A clear route to senior and leadership positions.