IT Business Process Analyst - West Chester, PA (Hybrid)

Role Summary

IT Business Process Analyst to support the local R&D laboratory computerised systems in West Chester, PA. Located in a hybrid environment (3 days/week in the office), the role involves implementing and maintaining laboratory IT solutions, ensuring compliance with relevant regulations and collaborating with cross-functional teams.

Responsibilities

• Support implementation of new solutions, testing, management, troubleshooting, and administration of new and existing systems within the pharmaceutical laboratory R&D organization.
• Support delivery of IT services and coordination with local, regional and global resources on project status, service and support efforts.
• Collaborate with laboratory business, staff, IT colleagues, vendors, and other stakeholders to support existing processes and technologies; identify requirements and assess impacts to IT delivery.
• Involved in implementation of new releases, upgrades and changes in accordance with Computer Systems Validation (CSV) standards.
• Perform day-to-day system administration, maintenance, and operational tasks for Lab systems; ensure service levels are developed and monitored.
• Configure PC/System specifications per vendor requirements; coordinate lab PC builds, user group management, data backup, test data backup/restore, IQ/OQ testing and documentation.
• Liaise with IT operational support for peripheral equipment (servers, desktops, printers, storage).
• Support SDLC tasks for laboratory computer systems; ensure implementations comply with FDA 21 CFR Part 11, GxP, and internal policies.
• Ensure Data Integrity compliance and remediation for Laboratory systems.
• Serve as site expert on laboratory computer systems (LIMS, IDBS Polar, Empower CDS, instrumentation, and other applications identified by management).
• Remotely support other Teva sites across multiple zones as needed.
• Backup and recovery management using Commvault.

Qualifications

• Required: Bachelor's degree in Computer Science, Information Systems Management, Computer Engineering, Electrical Engineering, Life Sciences, or related field.
• Required: Minimum 3 years of experience as a validation analyst or similar role (preferably in the pharmaceutical industry).
• Preferred: Minimum 6 years of experience as a validation analyst.
• Preferred: Extensive experience in regulated biotech/pharmaceutical/medical device companies and in regulated environments (GLP, GCP, GMP).
• Preferred: Experience with 21 CFR Part 11, GAMP; SDLC (Agile or Waterfall).
• Preferred: Experience providing end-user support in a highly regulated pharmaceutical environment; strong communication skills in English.
• Preferred: Knowledge of laboratory configurations, system software installation, and laboratory workflows.
• Required/Preferred: Strong organizational skills, problem-solving ability, and ability to work in a global, multi-disciplinary team.

Skills

• Knowledge of FDA/GxP regulatory expectations as they apply to laboratory systems.
• Experience with LIMS (Labware, Watson LIMS), IDBS Polar, Empower CDS, and other laboratory software.
• Experience with SDLC and regulatory compliance in laboratory environments.
• Strong verbal and written English communication.

Education

• Bachelor's degree in a related field (as listed in Qualifications).