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

Role Summary

IT Business Process Analyst to support local R&D laboratory computerised systems in West Chester, US. Location: hybrid opportunity (3 days/week in the office) in West Chester, PA.

Responsibilities

• Support implementation of new solutions, testing, management, troubleshooting, and administration of new and existing systems within the pharmaceutical laboratory research and development organization.
• Support delivery of IT services and coordination with local, regional and global resources on the status of projects, service and support efforts.
• Collaborate with laboratory business, staff, IT colleagues, vendors, and other stakeholders to support existing processes and technologies. Identify customer requirements; assess impacts to the delivery of applications and other IT functions.
• Involved in implementation of new releases, upgrades and changes in accordance with Computer Systems Validation (CSV) standards.
• Perform day-to-day system administration, maintenance & operational tasks for the Lab systems and ensures appropriate service levels are developed and monitored.
• Perform PC/System specification configuration according to vendor requirements, works with IT Operations for PC lab build, user group assignment and management, data backup setup and control, test data backup and restore, IQ/OQ test execution and documentation.
• Liaise with IT operational support teams for the peripheral equipment, such as servers, desktops, printers and storage devices.
• Support with tasks and deliverables related to Software Development Life Cycle (SDLC) phases for laboratory computer systems. Ensures that system implementations are in keeping with the relevant FDA 21 CFR Part 11, GxP guidelines as well as internal policies and processes.
• Ensure compliance with Data Integrity requirements and remediation activities for Laboratory systems.
• To be the site expert on all laboratory computer systems – LIMS (Labware), LIMS (Watson LIMS), IDBS Polar, CDS (Empower), standard-alone computer driven instrumentation and other applications identified by laboratory management.
• Remotely support other Teva sites across multiple zones as needed.
• Backup & recovery management Commvault.

Qualifications

• Required: Minimum 3 years of experience working in a validation analyst or similar role, preferably within the pharmaceutical industry.
• Preferred: Minimum 6 years of experience working as a validation analyst.
• Required: Extensive experience in regulated biotech, pharmaceutical, medical device, cosmetics, or food companies.
• Required: Experience in regulated environment (GLP, GCP or GMP).
• Required: Experience in 21 CFR Part 11, GAMP.
• Required: Experience in SDLC (Agile or Waterfall).
• Required: Experience in providing face-to-face and remote business analyst support to laboratory system users in a highly regulated environment within the Pharmaceutical Industry.
• Required: Excellent verbal and written English communication skills.
• Required: Knowledge of laboratory technical configurations and installation of system software and tools.
• Required: Knowledge of workflows in the laboratory space and ability to manage time and multiple tasks.
• Preferred: May have specialized external certification.

Skills

• Strong problem-solving skills
• Knowledge of FDA and laboratory compliance considerations (cGMP, 21 CFR Part 11, GxP)
• Collaborative, cross-functional communication in global teams
• Ability to support both face-to-face and remote end users in a regulated environment

Education

• Bachelor's degree - preferably in Computer Science, Information Systems Management, Computer Engineering, Electrical Engineering, Life Sciences or a related field.