Ecocareers ยท 2 weeks ago
Sr. Equipment Validation Engineer
Raritan, NJ
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expEcocareers is a confidential company seeking a Sr. Equipment Validation Engineer. The role involves monitoring lab instrument reviews, executing validations, and ensuring compliance and data integrity in laboratory operations.
Staffing & Recruiting
Responsibilities
Monitor due dates for lab instrument reviews and coordinate with stakeholders
Execute SOP-driven validations, produce IQ/OQ/PQ deliverables, and ensure ALCOA+ data integrity
Perform gap analyses, remediation plans, and efficiency enhancements for lab operations
Report metrics on validation status, closures, and compliance to internal teams
Coordinate system changes with QA/equipment owners, author validation protocols, and complete change documentation
Track periodic instrument reviews using schedulers, generate RTMs/VSRs, and finalize compliance artifacts
Lead team task assignments, deliver validation training, and drive multi-site demand planning for GMP upkeep
Qualification
Required
Minimum 8 years in GxP/analytical lab settings with hands-on validation of GMP instruments including HPLC, UV-VIS, FTIR, NMR, Polarimeter, XRD, Kaye Validators, and LIMS/Empower3 systems
Proven expertise in IQ/OQ/PQ protocols, RTM/VSR generation, SOP adherence, and 21 CFR Part 11/GAMP5 compliance
Experience leading offshore-onsite validation teams, assigning tasks, providing technical training, and managing multi-site equipment qualifications
Strong skills in change control (ServiceNow/Remedy), CAPA/deviation handling, gap analyses, and process improvements for lab efficiency
Ability to review/approve GMP deliverables (VMPs, test scripts, audit trails) in team environments with stakeholder collaboration and metrics reporting
Administer lab systems via ticketing (helpdesk, user access) while executing IQ/OQ/PQ for instruments like HPLC
Collaborate with analysts/owners to troubleshoot, validate, and resolve instrument issues per SOPs (onsite/remote)
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase