Senior Validation Engineer - cGMP Equipment & Cleaning

Apollo Professional Solutions; Oceanside (CA); On-site; USD 124,000 - 179,000; Full time

Job summary

Apollopros seeks a Validation Engineer (Contract) to support equipment and cleaning validation in a regulated biopharmaceutical manufacturing environment in Oceanside, CA. The role is onsite, five days a week, with standard PT hours.

You will author and execute IQ/OQ/PQ protocols, perform data analysis, and ensure compliant documentation per cGMP. Strong hands-on validation experience and cross-functional collaboration are essential.

Qualifications

• Bachelor's or Master's degree in Chemical/Biomedical/Mechanical Engineering or related
• 8–10+ years of validation engineering in cGMP biopharma/manufacturing
• Proven experience authoring/executing Equipment Validation and Cleaning Validation protocols
• Hands-on experience with IQ/OQ/PQ and validated systems like bioreactors, CIP/SIP, and stainless/ single-use setups

Responsibilities

• Author, review, execute, and summarize IQ/OQ/PQ validation protocols for equipment and systems.
• Develop and execute Cleaning Validation protocols; coordinate sampling and data analysis.
• Ensure compliance with cGMP, generate audit-ready documentation, and support regulatory readiness.

Skills

Technical writing

Cross-functional collaboration

Problem solving

Analytical thinking

Education

Bachelor's or Master's in Chemical Engineering

Biomedical Engineering

Biochemistry/Mechanical Engineering

Tools

Bioreactors

Chromatography skids

TFF systems

Autoclaves

CIP/SIP systems

Single-use equipment

Stainless steel systems

Job description

Apollopros seeks a Validation Engineer (Contract) to support equipment and cleaning validation in a regulated biopharmaceutical manufacturing environment in Oceanside, CA. The role is onsite, five days a week, with standard PT hours.

You will author and execute IQ/OQ/PQ protocols, perform data analysis, and ensure compliant documentation per cGMP. Strong hands-on validation experience and cross-functional collaboration are essential.