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 810 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

• Bachelors or Masters degree in Chemical Engineering Biomedical Engineering Mechanical Engineering Biochemistry or a related technical discipline.

• 810 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 /

Required Skills:

CQV Equipment Validation

Required Education:

Bachelors