Validation Engineer

Job Description

Job Description

BioPhase Solutions  specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Validation Engineer to work for a leading Greater Los Angeles area contract development and manufacturing organization.

Salary: $100-115k+/year depending on experience

Responsibilities:

• Draft and Review User Requirement Specifications (URS): Develop and refine URS for new and existing process equipment, ensuring alignment with manufacturing needs and regulatory standards.
• Perform Equipment Qualifications (IQ, OQ, PQ): Plan, execute, and document qualification protocols to verify equipment performance meets cGMP requirements and intended use.
• Execute Process Validation and Cleaning Validation: Identify critical process parameters, establish validation protocols, and conduct cleaning validations to maintain product quality and regulatory compliance.
• Generate and Maintain Validation Documentation: Prepare, review, and archive validation reports, SOPs, protocols, and related records to ensure clear traceability and audit readiness.
• Troubleshoot and Investigate Deviations: Collaborate with cross-functional teams to diagnose equipment and process issues, implement corrective actions (CAPA), and address audit observations promptly.
• Support Scale-Up and Technology Transfer Efforts: Work with manufacturing and development groups to optimize processes, facilitate seamless scale-up, and transfer validated methods across company sites.
• Coordinate with Cross-Functional Teams: Engage Quality, Process Development, and Manufacturing teams to meet project timelines, drive continuous improvement, and uphold cGMP standards.

Experience/Requirements:

• Bachelors in engineering, chemistry, or related field
• Certifications related to GMP compliance, quality systems, or validation preferred.
• 1–3+ years of experience in validation engineering or a closely related field in a cGMP-regulated pharma or biotech environment.
• Strong working knowledge of process validation, equipment qualification (IQ/OQ/PQ), and pharmaceutical manufacturing processes.
• Proficiency in drafting and reviewing validation documents (URS, SOPs, protocols, reports).
• Familiarity with deviation investigations, CAPA processes, and audit responses.
• Basic vendor management skills to evaluate and coordinate with external equipment/service providers.
• Competence in using data analysis tools and MS Office applications to track and report validation results. 

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