Valspec · 7 hours ago
Equipment Validation Engineer
Royersford, Pennsylvania, United States
Full-time
Onsite
Mid, Senior Level
3+ years expValspec is a global provider of system validation and lifecycle services, primarily serving the Life Sciences industry. They are seeking a highly motivated GMP Equipment Validation Engineer to support Commissioning, Qualification, and Validation (CQV) activities for manufacturing and utility equipment, ensuring compliance with regulatory standards and effective collaboration with client teams.
Software
No H1B
Responsibilities
Lead and execute CQV activities for GMP equipment including:
Autoclaves
CIP/SIP systems
Bioreactors
Incubators
Freezers
Refrigerators
Centrifuges
Washers
Controlled temperature units
Environmental chambers
HVAC systems
Clean steam generators
WFI systems
Process tanks
Utility systems (compressed air, nitrogen, etc.)
Develop and review validation documentation including URS, DQ, IQ, OQ, and PQ protocols and reports
Perform risk assessments and impact analyses to support validation strategy
Coordinate with client engineering, automation, and quality teams to ensure alignment on project goals and timelines
Troubleshoot and resolve equipment and process issues during commissioning and qualification phases
Maintain compliance with cGMP, FDA, and other applicable regulatory requirements
Provide timely updates and communicate effectively with client stakeholders
Qualification
Required
Bachelor's degree in engineering, Life Sciences, or related field
3+ years of experience in CQV within a GMP-regulated environment
Strong understanding of validation lifecycle and regulatory expectations
Excellent organizational and communication skills
Ability to work independently and manage multiple priorities
Preferred
Experience with automated systems and controls integration is a plus
Benefits
Premium medical coverage
401(k) with company match
Tuition reimbursement
Unique performance incentives
And more — all designed to support your growth, well-being, and future.
Company
Valspec
VALSPEC is the leading provider of computer system validation and system life cycle services including testing, commissioning, etc.
51-200 employees
Funding
Current Stage
Growth StageRecent News
2023-10-11
2022-11-11
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