BioPhase
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Base pay range
$98,000.00/yr - $112,000.00/yr BioPhase Solutions
specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a
Validation Engineer
for a manufacturing company in the Los Angeles area. Job Summary: The Validation Engineer is responsible for ensuring that critical process and equipment validations meet regulatory and quality standards, including developing and reviewing URS, performing equipment qualifications (IQ, OQ, PQ), and generating essential documentation. This role exists to maintain and enhance compliance within the manufacturing process, preventing delays and mitigating risks associated with deviations or audit findings. By guaranteeing robust validation practices, the Validation Engineer directly supports the company’s commitment to delivering high-quality products on time. Salary:
$98k-$112k per year Key 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 the company’s sites. Coordinate with Cross-Functional Teams: Engage Quality, Process Development, and Manufacturing teams to meet project timelines, drive continuous improvement, and uphold cGMP standards. Qualifications: Bachelor’s degree in engineering, Chemistry, or a related scientific discipline. Certifications related to GMP compliance, quality systems, or validation (preferred). Early-career experience (1–3 years) in validation engineering or a closely related field within a cGMP-regulated pharmaceutical or biotech environment. Foundational understanding of process validation, equipment qualification (IQ/OQ/PQ), and pharmaceutical manufacturing processes. Working knowledge of process validation and equipment qualification within a cGMP framework. 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. Work Environment & Physical Demands: Ability to work on the production floor and in laboratory settings, which may involve standing or walking for extended periods. Capacity to lift or move light-to-moderate equipment or materials when necessary (in accordance with safety guidelines). Main work setting is an office environment with regular coordination of validation activities. Occasionally in cGMP-compliant manufacturing and lab environment requiring Personal Protective Equipment (PPE). May involve occasional cleanroom work with strict gowning requirements. Collaborative setting with cross-functional teams, balancing office-based tasks (documentation, analysis) and hands-on activities. Seniority level
Mid-Senior level Employment type
Full-time Job function
Engineering, Research, and Quality Assurance Industries
Staffing and Recruiting, Biotechnology Research, and Research Services
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$98,000.00/yr - $112,000.00/yr BioPhase Solutions
specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a
Validation Engineer
for a manufacturing company in the Los Angeles area. Job Summary: The Validation Engineer is responsible for ensuring that critical process and equipment validations meet regulatory and quality standards, including developing and reviewing URS, performing equipment qualifications (IQ, OQ, PQ), and generating essential documentation. This role exists to maintain and enhance compliance within the manufacturing process, preventing delays and mitigating risks associated with deviations or audit findings. By guaranteeing robust validation practices, the Validation Engineer directly supports the company’s commitment to delivering high-quality products on time. Salary:
$98k-$112k per year Key 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 the company’s sites. Coordinate with Cross-Functional Teams: Engage Quality, Process Development, and Manufacturing teams to meet project timelines, drive continuous improvement, and uphold cGMP standards. Qualifications: Bachelor’s degree in engineering, Chemistry, or a related scientific discipline. Certifications related to GMP compliance, quality systems, or validation (preferred). Early-career experience (1–3 years) in validation engineering or a closely related field within a cGMP-regulated pharmaceutical or biotech environment. Foundational understanding of process validation, equipment qualification (IQ/OQ/PQ), and pharmaceutical manufacturing processes. Working knowledge of process validation and equipment qualification within a cGMP framework. 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. Work Environment & Physical Demands: Ability to work on the production floor and in laboratory settings, which may involve standing or walking for extended periods. Capacity to lift or move light-to-moderate equipment or materials when necessary (in accordance with safety guidelines). Main work setting is an office environment with regular coordination of validation activities. Occasionally in cGMP-compliant manufacturing and lab environment requiring Personal Protective Equipment (PPE). May involve occasional cleanroom work with strict gowning requirements. Collaborative setting with cross-functional teams, balancing office-based tasks (documentation, analysis) and hands-on activities. Seniority level
Mid-Senior level Employment type
Full-time Job function
Engineering, Research, and Quality Assurance Industries
Staffing and Recruiting, Biotechnology Research, and Research Services
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