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 :

Please send resumes to mia@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!