Senior Validation Engineer - CQV

Our client, a world leader in biotechnology and life sciences, is seeking a "Senior validation Engineer - CQV".

Location: Oceanside, CA

Duration: Long-Term Contract (Possibility Of Further Extension)

Pay Rate: $85/hr on W2

Company Benefits: Medical, Dental, Vision, Paid Sick Leave, 401K

Job Summary:

The role will focus on equipment qualification and cleaning validation activities supporting commercial stainless steel and single-use manufacturing operations.

The ideal candidate will have 8–10+ years of hands-on validation engineering experience in a cGMP biopharmaceutical manufacturing environment, with expertise in equipment qualification, CIP/SIP systems, and cleaning validation.

Key Responsibilities

• Author, review, and execute equipment qualification protocols, including IQ, OQ, and PQ.
• Develop and execute cleaning validation and cleaning verification protocols.
• Perform sampling activities, visual inspections, and coordinate analytical testing, including TOC, conductivity, bioburden, and endotoxin.
• Support qualification of biopharmaceutical manufacturing equipment, including bioreactors, chromatography skids, TFF systems, and autoclaves.
• Evaluate validation results against established acceptance criteria.
• Troubleshoot execution discrepancies and prepare protocol exceptions in collaboration with cross-functional teams.
• Maintain accurate validation documentation and records in compliance with cGMP and company quality standards.
• Support continuous improvement initiatives within validation processes.

Required Qualifications

• Bachelor's or Master's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biochemistry, or a related technical discipline.
• 8–10+ years of direct validation engineering experience in a cGMP biopharmaceutical or biotechnology manufacturing facility.
• Hands-on experience authoring and executing equipment qualification protocols (IQ/OQ/PQ).
• Direct experience with cleaning validation and cleaning verification.
• Working knowledge of CIP/SIP systems, residue limits, and recovery studies.
• Experience with stainless steel and single-use manufacturing equipment.
• Knowledge of GMP requirements and validation documentation practices.

Preferred Technical Experience

• Bioreactors and fermentation systems
• Chromatography skids
• Tangential Flow Filtration (TFF) systems
• Autoclaves
• TOC and conductivity testing
• Bioburden and endotoxin testing
• Cleaning validation sampling plans and analytical data review

If interested, please share your updated resume at hr@dawarconsulting.com/kavitha@dawarconsulting.com