Lead Validation Engineer – GMP Pharma (Onsite)

Actalent; Clayton (NC); On-site; USD 83,000 - 124,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

PTO / Vacation

Job summary

Actalent is seeking a Validation Engineer in Clayton, NC for on-site responsibilities in a GMP-regulated pharmaceutical environment.

The role focuses on leading validation activities, developing documentation, and ensuring compliance with FDA/EU Annex 15 standards while coordinating with engineering, quality, and manufacturing teams to support facility upgrades and ongoing operations.

Qualifications

• Experience with validation within GMP-regulated pharma/manufacturing environment.
• Ability to develop, author, execute, and report IQ/OQ/PQ and Process Validation protocols.
• Familiarity with regulatory requirements such as GMP, FDA expectations, and EU Annex 15.

Responsibilities

• Lead validation efforts from requirements through decommissioning.
• Develop, revise, and maintain validation documentation including plans and reports.
• Author, execute, and report on IQ, OQ, PQ, and Process Validation activities.

Skills

Validation experience

GMP knowledge

IQ/OQ/PQ expertise

Regulatory compliance

Documentation skills

Tools

TIMS (HP ALM)

VeeVa (QualityDocs)

VaultQuality

Job description

Actalent is seeking a Validation Engineer in Clayton, NC for on-site responsibilities in a GMP-regulated pharmaceutical environment.

The role focuses on leading validation activities, developing documentation, and ensuring compliance with FDA/EU Annex 15 standards while coordinating with engineering, quality, and manufacturing teams to support facility upgrades and ongoing operations.