Validation Engineering

Job Description Senior Validation Engineer

Employment Type: Full-Time

We are seeking an experienced Senior Validation Engineer to lead validation activities supporting our cGMP manufacturing operations. This role is responsible for validating equipment, facilities, utilities, manufacturing processes, and computerized systems while ensuring compliance with FDA cGMP requirements and industry best practices.

The ideal candidate has a strong technical background in pharmaceutical, medical device, cosmetic, or regulated manufacturing environments and enjoys working cross-functionally with Engineering, Quality, Manufacturing, Regulatory Affairs, Maintenance, and R&D.

Plan and execute validation activities for new equipment, facilities, utilities, and manufacturing processes.

Support new product launches and continuous process improvement initiatives.

Lead equipment qualification and process validation projects from planning through implementation.

Support engineering change controls and assess validation impact for equipment and process changes.

Perform periodic reviews and revalidation of equipment, utilities, and manufacturing processes.

Ensure compliance with FDA cGMP regulations, ISPE guidance, and internal quality standards.

Maintain validation records, equipment logbooks, and supporting documentation.

Collaborate with Maintenance, Engineering, Manufacturing, Quality Assurance, Regulatory Affairs, and R&D to resolve technical issues and implement improvements.

Systems & Equipment Experience

HVAC systems

Purified Water / RODI Water Systems

Compressed Air and Gas Systems

Boilers and Chillers

Manufacturing Equipment

Laboratory Equipment

Bachelor's degree in Engineering, Life Sciences, or a related technical field (or equivalent experience).

• 3–5+ years of validation experience in a pharmaceutical, medical device, cosmetic, or other FDA-regulated manufacturing environment.
• Experience with equipment, facility, utility, and process validation.
• Experience with engineering change controls and validation documentation.
• Strong technical writing and documentation skills.
• Ability to manage multiple projects while meeting deadlines.

Experience with software validation and 21 CFR Part 11 compliance.

Knowledge of risk-based validation methodologies.

Familiarity with Lean Manufacturing or Continuous Improvement initiatives.

The successful candidate is a hands-on validation professional who enjoys solving technical problems, improving manufacturing processes, and working collaboratively across departments. This individual is organized, detail-oriented, and committed to maintaining the highest standards of quality and regulatory compliance.

Fast growing liquid pour contract manufacturer of premium health and beauty products.

About Us\r\nFast growing liquid pour contract manufacturer of premium health and beauty products.