What are the responsibilities and job description for the Validation Engineer position at BioPhase Solutions?
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.
Please send resumes to mia@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!
Salary : $100,000 - $115,000
