BioTalent
Utilities & Process Validation Engineer
BioTalent, San Diego, California, United States, 92189
This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$55.00/hr - $65.00/hr Job Title:
Utilities & Process Validation Engineer Position Summary
The Utilities & Process Validation Engineer is responsible for planning, executing, and documenting validation activities for facility systems, utilities (e.g. water, steam, HVAC, compressed gases, clean rooms), and process equipment in a regulated environment (medical device / diagnostics). This role ensures systems operate consistently and meet all applicable regulatory, quality, and safety standards (e.g. FDA, ISO 13485, GMP). Key Responsibilities
Develop validation strategy, plans, protocols, and reports (IQ, OQ, PQ, system performance qualification, requalification, periodic reviews) for facility, utilities, process equipment, and support systems. Define acceptance criteria, test methods, sampling plans, and controls for validation. Perform validation execution: install checks, functional testing, challenge testing, monitoring, data collection, calibration, troubleshooting deviations. Lead or support qualification of new or modified equipment or facility systems (e.g. HVAC, clean steam, WFI/RO, compressed air, HVAC zones, utilities, process piping). Conduct risk assessments, gap analyses, and process capability / statistical analysis as needed. Coordinate with cross-functional teams: engineering, project management, quality, manufacturing, maintenance, and facilities. Review design specifications, vendor documentation, and ensure that design meets validation needs. Oversee revalidation / periodic review of systems; monitor for drift or changes over time. Investigate validation failures / deviations, root-cause analysis, CAPA implementation. Maintain validation master plan, document control, and ensure traceability of validation documentation. Support audits / inspections and respond to regulatory / audit queries. Qualifications / Requirements
Bachelor’s degree in engineering (Mechanical, Chemical, Biomedical, or equivalent). Advanced degree a plus. 5+ years of experience in process / utilities / facility validation in a regulated industry (pharma, biotech, medical device, diagnostics). Deep knowledge of validation protocols (IQ / OQ / PQ), GMP, regulatory expectations (FDA, ISO 13485, etc.). Experience with utilities: HVAC, clean steam, WFI/RO, compressed air, gases, HVAC zones, etc. Statistical analysis skills (e.g. capability, control charts). Strong skills in documentation, writing protocols and reports, and attention to detail. Ability to lead validation projects, manage time, coordinate among stakeholders. Experience investigating and resolving deviations / CAPAs. Excellent communication skills, ability to present to quality / management / regulatory audiences. Relevant certifications (e.g. ASQ, or validations training) are a plus.
#J-18808-Ljbffr
$55.00/hr - $65.00/hr Job Title:
Utilities & Process Validation Engineer Position Summary
The Utilities & Process Validation Engineer is responsible for planning, executing, and documenting validation activities for facility systems, utilities (e.g. water, steam, HVAC, compressed gases, clean rooms), and process equipment in a regulated environment (medical device / diagnostics). This role ensures systems operate consistently and meet all applicable regulatory, quality, and safety standards (e.g. FDA, ISO 13485, GMP). Key Responsibilities
Develop validation strategy, plans, protocols, and reports (IQ, OQ, PQ, system performance qualification, requalification, periodic reviews) for facility, utilities, process equipment, and support systems. Define acceptance criteria, test methods, sampling plans, and controls for validation. Perform validation execution: install checks, functional testing, challenge testing, monitoring, data collection, calibration, troubleshooting deviations. Lead or support qualification of new or modified equipment or facility systems (e.g. HVAC, clean steam, WFI/RO, compressed air, HVAC zones, utilities, process piping). Conduct risk assessments, gap analyses, and process capability / statistical analysis as needed. Coordinate with cross-functional teams: engineering, project management, quality, manufacturing, maintenance, and facilities. Review design specifications, vendor documentation, and ensure that design meets validation needs. Oversee revalidation / periodic review of systems; monitor for drift or changes over time. Investigate validation failures / deviations, root-cause analysis, CAPA implementation. Maintain validation master plan, document control, and ensure traceability of validation documentation. Support audits / inspections and respond to regulatory / audit queries. Qualifications / Requirements
Bachelor’s degree in engineering (Mechanical, Chemical, Biomedical, or equivalent). Advanced degree a plus. 5+ years of experience in process / utilities / facility validation in a regulated industry (pharma, biotech, medical device, diagnostics). Deep knowledge of validation protocols (IQ / OQ / PQ), GMP, regulatory expectations (FDA, ISO 13485, etc.). Experience with utilities: HVAC, clean steam, WFI/RO, compressed air, gases, HVAC zones, etc. Statistical analysis skills (e.g. capability, control charts). Strong skills in documentation, writing protocols and reports, and attention to detail. Ability to lead validation projects, manage time, coordinate among stakeholders. Experience investigating and resolving deviations / CAPAs. Excellent communication skills, ability to present to quality / management / regulatory audiences. Relevant certifications (e.g. ASQ, or validations training) are a plus.
#J-18808-Ljbffr