Contract Biopharma Validation Engineer – Onsite Oceanside

ACTalent; Oceanside (CA); On-site; USD 83,000 - 110,000; Full time

Benefits offered by this job

Medical

Dental & Vision

Disability insurance

HSA

401(k) plan

Job summary

Actalent seeks a Validation Engineer (Contractor) to lead qualification and cleaning validation across stainless steel and single-use systems at a Oceanside biopharma facility. You will author, execute, and summarize GMP-ready protocols, ensuring data integrity and regulatory compliance.

You will work with manufacturing, QA, and engineering, independently managing timelines and deliverables while supporting continuous improvement in validation practices.

Qualifications

• 810 years of direct validation engineering experience within a cGMP biopharmaceutical or biotechnology manufacturing facility.
• Hands-on authoring and executing equipment validation protocols (IQ/OQ/PQ) for bioreactors, chromatography skids, TFF systems, and autoclaves.
• Direct experience with cleaning validation, CIP and SIP, residue limit determination and recovery studies.
• Strong understanding of cGMP and GMP requirements in biopharma environments.
• Experience coordinating analytical testing data for TOC, conductivity, bioburden, and endotoxin.
• Excellent technical writing for validation documentation.
• Strong cross-functional collaboration and communication across engineering, manufacturing and quality.
• Ability to manage timelines and deliver validation projects independently.

Responsibilities

• Author, review, and execute IQ/OQ/PQ protocols for diverse manufacturing systems.
• Develop and execute cleaning validation and verification protocols with sampling plans.
• Evaluate results against acceptance criteria and document protocol exceptions.
• Perform CIP/SIP validation activities and residue recovery studies.
• Maintain traceability and data integrity per cGMP requirements.

Skills

IQ/OQ/PQ protocols

Validation engineering

cGMP knowledge

Technical writing

Cross-functional collaboration

Independent scheduling

SIP/CIP validation

GMP compliance

QA documentation

Education

B.S. or M.S. in Chemical/Biomedical/Mechanical Engineering or Biochemistry

Tools

TOC

Conductivity testing

Bioburden testing

Endotoxin testing

Job description

Actalent seeks a Validation Engineer (Contractor) to lead qualification and cleaning validation across stainless steel and single-use systems at a Oceanside biopharma facility. You will author, execute, and summarize GMP-ready protocols, ensuring data integrity and regulatory compliance.

You will work with manufacturing, QA, and engineering, independently managing timelines and deliverables while supporting continuous improvement in validation practices.