Senior Validation Engineer - Onsite Aseptic GMP IQ/OQ/PQ

Actalent; Costa Mesa (CA); On-site; USD 117,000 - 130,000; Full time

Benefits offered by this job

Medical

Dental

Vision

PTO

Sick time

Holiday Pay

Job summary

Actalent is seeking a Senior Validation Engineer for Costa Mesa, CA, to lead hands-on qualification in a sterile pharmaceutical manufacturing environment. You will author IQ/OQ/PQ protocols, execute field validation, and prepare final reports while collaborating with manufacturing, engineering, quality, and operations teams.

The role requires 7+ years of validation experience in a regulated setting, strong technical writing, and the ability to work on the manufacturing floor.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 7+ years of validation experience in pharmaceutical or biopharmaceutical manufacturing.
• Experience in sterile/aseptic/injectable environments.
• Hands-on experience executing IQ/OQ/PQ protocols and field validation.
• Strong technical writing and documentation skills.
• Experience qualifying equipment and critical utilities.
• GMP knowledge and regulated manufacturing experience.

Responsibilities

• Author and execute IQ, OQ, and PQ protocols for pharmaceutical equipment and systems.
• Perform hands-on field qualification activities on the manufacturing floor.
• Review data, analyze results, and prepare final validation reports.
• Investigate discrepancies or deviations during protocol execution.
• Support qualification of equipment like aseptic filling systems, autoclaves, lyophilizers, isolators/RABS, CIP/SIP, sterile filtration.
• Support qualification of utilities including WFI, clean steam, HVAC, compressed air, nitrogen.
• Engage in process and cleaning validation and aseptic manufacturing activities.
• Support changes, deviations, CAPAs, and risk assessments; ensure FDA/cGMP compliance.

Skills

IQ/OQ/PQ

Validation

GMP

Technical writing

Field validation

Sterile manufacturing

Equipment qualification

Risk assessment

Education

Bachelor's degree in Engineering

Job description

Actalent is seeking a Senior Validation Engineer for Costa Mesa, CA, to lead hands-on qualification in a sterile pharmaceutical manufacturing environment. You will author IQ/OQ/PQ protocols, execute field validation, and prepare final reports while collaborating with manufacturing, engineering, quality, and operations teams.

The role requires 7+ years of validation experience in a regulated setting, strong technical writing, and the ability to work on the manufacturing floor.