Equipment Lifecycle Management & Data Integrity Analyst

Required Skills & Experience

Bachelor's degree in a scientific, engineering, or technical discipline. 2-6 years of experience supporting GMP-regulated laboratory or Quality environments. 2+ years of experience supporting qualification, validation, or lifecycle management of GMP analytical instrumentation. Experience drafting and executing qualification protocols, reports, and technical documentation. Strong understanding of Good Documentation Practices (GDP), GMP regulations, and GxP requirements. Familiarity with data integrity principles and 21 CFR Part 11 requirements. Experience supporting laboratory equipment maintenance, troubleshooting, qualification, or lifecycle activities. Strong technical writing and documentation skills. Ability to work onsite in a regulated laboratory environment and collaborate across multiple functional teams.

Nice to Have Skills & Experience

Experience supporting Quality Control laboratory operations. Experience with Equipment Lifecycle Management (ELM) programs. Exposure to systems such as Comet, Empower, SAP, Meridian, TruVault, KNEAT, or similar regulated laboratory systems. Experience supporting inspection readiness, remediation programs, or compliance initiatives. Knowledge of USP, EP, and compendial laboratory standards. Experience conducting risk assessments and supporting investigations/CAPA activities. Self-starter with strong communication skills and a collaborative, team-oriented approach.

Job Description

One of our large pharmaceutical clients is seeking an Equipment Lifecycle Management (ELM) & Data Integrity Analyst to support a proactive Inspection Readiness initiative within the Quality organization in Malvern, PA. This individual will play a key role in the lifecycle management, qualification, maintenance, and data integrity oversight of GMP analytical instruments across multiple Quality Control laboratories. The ideal candidate combines hands-on experience supporting laboratory equipment qualification and lifecycle activities with a strong understanding of GMP compliance, data integrity principles, and quality documentation practices. This role will partner closely with Quality, QA, Laboratory Operations, Automation, and Equipment Lifecycle Management SMEs to ensure laboratory systems remain inspection-ready and compliant.

Responsibilities

Support the full lifecycle management of GMP analytical instruments across Quality Control laboratories. Draft, execute, and maintain qualification protocols, reports, operating procedures, and supporting validation documentation. Coordinate equipment installations, preventative maintenance, vendor activities, troubleshooting efforts, and equipment onboarding activities. Partner with vendors, laboratory personnel, QA, and technical SMEs to resolve equipment and compliance-related issues. Participate in equipment qualification, requalification, and remediation activities. Perform data integrity assessments of laboratory equipment and associated systems. Develop process flow documentation and support risk assessments for laboratory systems and data management practices. Author and maintain GMP documentation including risk assessments, technical reports, investigations, CAPA support documentation, and quality records. Support investigation activities by partnering with QA and laboratory teams to identify root causes and implement corrective actions. Assist with inspection readiness initiatives by identifying compliance gaps and supporting remediation efforts. Participate in cross-functional project teams supporting continuous improvement and quality initiatives.