Laboratory Instrumentation Qualification & Project Management Specialist

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 standards. This 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 careers.abbvie.com .

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 :

Bachelor’s degree in Engineering, Chemistry, Biology, or a related scientific discipline plus 5+ years of GMP validation experience, including ≥3 years in laboratory instrumentation qualification careers.abbvie.com .

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.

Master’s degree in a scientific discipline.

To Apply :

Please submit your résumé highlighting your laboratory-instrumentation qualification projects and project-management experience. We look forward to partnering with you through year-end and beyond.