Job Description
Job DescriptionBioPhase 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!!!