Job Description
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.
Please send resumes to mia@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!
Numbers & Facts
| Location | Los Angeles, CA |
| Industry | Accounting and Auditing Services |
| Salary | $100,000–$115,000 Per Year |
| Company Size | 20 to 49 employees |
| Year Founded | 1998 |
| Website | http://www.biophaseinc.com/ |
About Company
Our mission is to have a profound and positive impact on the performance of Biotechnology and Pharmaceutical companies in California by providing high quality scientific, clinical research and administrative personnel to such a noble industry. Whether you are a recent life science graduate or a seasoned clinical research associate looking for a managerial opening, BioPhase Solutions can locate the right opportunity to fit all your needs.
Skills
- Biotech and Pharmaceuticalunmatched
- Chemistryunmatched
- Continuous Improvementunmatched
- Contract Manufacturingunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Data Analysisunmatched
- Drug Manufacturingunmatched
- Equipment Maintenance/Repairunmatched
- Equipment Validationunmatched
- GMP (Good Manufacturing Practices)unmatched
- Identify Issuesunmatched
- Manufacturingunmatched
- Manufacturing Requirementsunmatched
- Manufacturing/Industrial Processesunmatched
- Microsoft Officeunmatched
- Process Developmentunmatched
- Process Improvementunmatched
- Process Manufacturingunmatched
- Process Validationunmatched
- Product Testingunmatched
- Quality Managementunmatched
- Regulatory Complianceunmatched
- Standard Operating Procedures (SOP)unmatched
- System Validationunmatched
- Time Managementunmatched
- Traceabilityunmatched
- Validation Documentationunmatched
- Validation Planunmatched
- Vendor/Supplier Managementunmatched
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