IT Business Process Analyst III

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

We are currently recruiting an IT Business Process Analyst to support the local R&D laboratory computerised systems in West Chester, US.

How you’ll spend your day

Key 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), 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.

Your experience and qualifications

Qualifications 
•    Required: Bachelor’s Degree - preferably in Computer Science, Information Systems Management, Computer Engineering, Electrical Engineering, Life Sciences or a related field.

Key Skills and Experience 
•    Experience working in a highly regulated environment within the pharmaceutical laboratory environment.
•    Knowledge and experience of cGMP and its implementation to laboratory instrumentation and laboratory processes.
•    Experience in providing face-to-face and remote end user support to laboratory users and applications in a highly regulated environment within the Pharmaceutical Industry.
•    Excellent verbal and written English communication skills.
•    Knowledge of laboratory technical configurations
•    Knowledge of installation of system software and tools
•    Knowledge of workflows in the laboratory space.
•      Excellent Organizational Skills - ability to manage time and multiple tasks
•      Strong problem-solving skills
•     May have specialized external certification.
•     Has developed proficiency in a range of IT processes or procedures through job-related training and considerable on-the-job experience in a laboratory environment

Experience:
 
•    Proven experience working as a validation analyst
•    Extensive experience in regulated biotech or pharmaceutical companies
•    Experience in regulated environment (GLP, GCP or GMP)
•    Experience in 21 CFR Part 11, GAMP
•    Experience in SDLC (Agile or Waterfall)
•    Experience in providing face-to-face and remote business analyst support to laboratory system users in a highly regulated environment within the Pharmaceutical Industry.
•    Successful experience working in a team environment and with a multi-disciplinary and global team.

Enjoy a more rewarding choice