VA
Validation Engineer
Accepting applicationsVirtue America · Washington, United States
Full-Time Mid_senior aiarmate
Posted
2d ago
Category
Manufacturing
Experience
Mid_senior
Country
United States
Job Title: Senior Validation Engineer– Pharma Plant Operations
Location: Washington (WA)
Experience Required: 10–15+ Years
Industry: Pharmaceutical / Biotech Manufacturing
Job Description:
We are seeking a highly experienced Validation engineer to oversee and drive validation operations for a pharmaceutical manufacturing plant. This role requires a strong technical leader with extensive experience managing validation activities across manufacturing, packaging, and utility systems, specifically including cappers, fillers, and packaging equipment within regulated pharma environments.
The ideal candidate will have hands-on expertise in plant startup/support activities, team leadership, compliance management, and end-to-end validation lifecycle execution.
Key Responsibilities:
Lead site-wide validation activities for manufacturing and packaging operations.
Manage validation strategy and execution for:
Cappers
Fillers
Packaging lines
Utilities
Process equipment
Automated manufacturing systems
Oversee execution of Commissioning, Qualification, and Validation (CQV) activities including IQ/OQ/PQ.
Provide leadership to validation engineers, contractors, and cross-functional teams.
Ensure compliance with FDA, cGMP, GAMP5, and data integrity requirements.
Drive deviation investigations, CAPA implementation, and change control assessments.
Support regulatory inspections and audit readiness initiatives.
Collaborate with QA, Manufacturing, Engineering, Automation, and Maintenance teams to ensure operational excellence.
Review and approve validation protocols, reports, SOPs, and technical documentation.
Support equipment startup, tech transfer, and process optimization initiatives.
Lead continuous improvement efforts across validation and compliance programs.
Required Qualifications:
10–15+ years of experience in pharmaceutical/biotech validation environments.
Strong leadership experience managing validation activities within a pharma manufacturing plant.
Extensive hands-on experience with cappers, fillers, and packaging systems.
Strong knowledge of aseptic processing, fill-finish operations, and GMP manufacturing.
Proven experience leading teams and interacting with senior plant leadership.
Excellent understanding of FDA regulations, cGMP standards, and validation lifecycle management.
Strong communication, technical writing, and stakeholder management skills.
Preferred Qualifications
Bachelor’s degree in Engineering or related technical field.
Experience supporting commercial manufacturing facilities.
Prior experience in plant expansion, startup, or remediation projects preferred.
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Location: Washington (WA)
Experience Required: 10–15+ Years
Industry: Pharmaceutical / Biotech Manufacturing
Job Description:
We are seeking a highly experienced Validation engineer to oversee and drive validation operations for a pharmaceutical manufacturing plant. This role requires a strong technical leader with extensive experience managing validation activities across manufacturing, packaging, and utility systems, specifically including cappers, fillers, and packaging equipment within regulated pharma environments.
The ideal candidate will have hands-on expertise in plant startup/support activities, team leadership, compliance management, and end-to-end validation lifecycle execution.
Key Responsibilities:
Lead site-wide validation activities for manufacturing and packaging operations.
Manage validation strategy and execution for:
Cappers
Fillers
Packaging lines
Utilities
Process equipment
Automated manufacturing systems
Oversee execution of Commissioning, Qualification, and Validation (CQV) activities including IQ/OQ/PQ.
Provide leadership to validation engineers, contractors, and cross-functional teams.
Ensure compliance with FDA, cGMP, GAMP5, and data integrity requirements.
Drive deviation investigations, CAPA implementation, and change control assessments.
Support regulatory inspections and audit readiness initiatives.
Collaborate with QA, Manufacturing, Engineering, Automation, and Maintenance teams to ensure operational excellence.
Review and approve validation protocols, reports, SOPs, and technical documentation.
Support equipment startup, tech transfer, and process optimization initiatives.
Lead continuous improvement efforts across validation and compliance programs.
Required Qualifications:
10–15+ years of experience in pharmaceutical/biotech validation environments.
Strong leadership experience managing validation activities within a pharma manufacturing plant.
Extensive hands-on experience with cappers, fillers, and packaging systems.
Strong knowledge of aseptic processing, fill-finish operations, and GMP manufacturing.
Proven experience leading teams and interacting with senior plant leadership.
Excellent understanding of FDA regulations, cGMP standards, and validation lifecycle management.
Strong communication, technical writing, and stakeholder management skills.
Preferred Qualifications
Bachelor’s degree in Engineering or related technical field.
Experience supporting commercial manufacturing facilities.
Prior experience in plant expansion, startup, or remediation projects preferred.
Show more Show less