Laboratory Instrumentation Qualification & Project Management Specialist
Laboratory Instrumentation Qualification & Project Management Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Position Overview
We are seeking a highly skilled specialist to support the qualification and requalification of laboratory instrumentation combined with project management oversight. You will plan execute and document validation activities for analytical and process equipment ensuring all work aligns with GMP ISO and corporate role partners closely with R&D Quality and Engineering teams to deliver timely compliant qualification deliverables.
Key Responsibilities
Qualification Strategy & Execution
Develop execute and close out IQ/OQ/PQ protocols for laboratory instruments (e.g. HPLC GC spectrophotometers environmental chambers)
Requalify existing equipment per calibration and maintenance schedules.
Project Management & Coordination
Create and maintain project plans schedules and budgets for validation activities.
Coordinate validation tasks with third-party vendors lab scientists and site stakeholders.
Track milestones and deliverables; proactively escalate risks and implement mitigation plans.
Documentation & Compliance
Author and review validation documentation (URS SDS trace matrices final validation reports) in compliance with 21 CFR Part 11 GMP and ISO requirements .
Manage electronic quality-system entries deviations and CAPA related to instrumentation qualification.
Cross-Functional Collaboration
Facilitate kick-off design-review and project-status meetings; document action items and follow up to completion.
Provide training and technical support to lab personnel on qualified instruments and associated procedures.
Continuous Improvement
Identify process gaps and drive improvements in validation workflows and quality systems.
Stay current on industry best practices and emerging technologies in lab instrumentation.
Minimum Qualifications
Education & Experience:
Bachelors degree in Engineering Chemistry Biology or a related scientific discipline plus 5 years of GMP validation experience including 3 years in laboratory instrumentation qualification .
Technical Skills:
Expert in IQ/OQ/PQ protocol development and execution.
Familiarity with GMP 21 CFR Part 11 ISO 9001/17025 and Good Documentation Practices.
Proficient with electronic quality systems (e.g. Veeva Vault TrackWise) and LIMS.
Project Management:
Demonstrated ability to manage complex validation projects schedules and vendor engagements.
Skilled in Microsoft Project or equivalent planning tool.
Soft Skills:
Strong written/verbal communication (English/Spanish).
Detail-oriented organized and capable of working independently under tight timelines.
Preferred Qualifications
Experience with temperature mapping sterilization validation and environmental monitoring.
PMP or similar project-management certification.
Masters degree in a scientific discipline.
To Apply:
Please submit your rsum highlighting your laboratory-instrumentation qualification projects and project-management experience. We look forward to partnering with you through year-end and beyond.
Required Experience:
Unclear Seniority
Employment Type
Contract
