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Business Technology Analyst - CSV

Branchburg Township, New Jersey

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Req ID R-7545 Title Business Technology Analyst - CSV City Branchburg State / Province New Jersey Country United States

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Lilly was founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: "Take what you find here and make it better and better." 

More than 140 years later, we remain committed to his vision through every aspect of our business and the people we serve starting with those who take our medicines, and extending to health care professionals, employees and the communities in which we live. Our purpose is to unite caring with discovery to create medicines that make life better for people around the world.

We also have three long-established core values that guide all that we do at Lilly: Integrity, Excellence and Respect for People.

The Branchburg Site is an integral partner in Lilly’s API manufacturing network responsible for world-wide drug substance supply of targeted biologics. Information and Digital Solutions plays a critical role in delivery of our products.

This position provides computer system validation support for lab and manufacturing computerized instruments and systems. Develops and reviews computer system validation deliverables including Information and Digital Solution policies and procedures. Deploys and supports laboratory systems to meet business, regulatory, safety, data integrity and security needs. Requires business area knowledge and computer expertise to provide in-depth validation support for new and existing manufacturing and laboratory computerized instruments and systems.

Responsibilities

  • Perform and lead computer system validation projects related to authoring and executing specifications and validation documentation for manufacturing and laboratory computerized instruments and systems according to the Lilly Global Computer Systems Quality policies and practices.
  • Ensure that site Computer System Inventory list is maintained in the IT CMDB and remains current.
  • Author validation protocols, such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports and related Change Controls, ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e. 21 CFR Part 11, Sarbanes Oxley, GxP, privacy data practices, local and corporate policies).
  • Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations. Requirements related to the business use, data integrity, security, access, safety must be considered.
  • Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan. Prepare validation summary reports for executed protocols. Author security administration and system support standard operating procedures, and audit trail review work instructions as appropriate.
  • Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures and practices. Work with System Owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures. Facilitate a continuous improvement culture within the Manufacturing and Lab areas supported.
  • Investigate and resolve Deviations, CAPA investigations and other potential data integrity issues.
  • Responsible for the delivery of all CSV lifecycle deliverables in the for single and multi-user Computerized Systems.
  • Foster professional and inclusive behavior, invite new ideas and differing perspectives among team members, assuring an on-going positive relationship with the customers and other members of the IDS organization. Inspire and recognize teamwork.
  • Stay active and current in business technology trends, direction and innovation related to business process and technology areas of focus by participating in external forums, conferences, and other venues as necessary.
  • Ensure compliance to corporate and site policies and procedures to be audit ready, mitigate risk and follow quality management practices. Support and abide by applicable Lilly policies as indicated in the Lilly Red Book and other company policies and procedures. All corporate compliance training requirements must be met as required and defined.

Basic Qualifications

  • BS/BA required in Computer/Electrical Engineering or other relevant scientific field
  • 3+ years IT or equivalent relevant experience
  • Minimum of 2+ years in the Life Sciences industry
  • Proven experience in a regulated environment within areas of responsibility is required

Additional Skills/Preferences

  • MS/MBA desirable
  • Previous experience with managing external (vendor, consultant) business partners
  • Knowledge of TrackWise and HP ALM preferred
  • Ability to work on multiple concurrent project initiatives
  • Must maintain excellent working knowledge of Pharmaceutical regulations (e.g. cGMP’s, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.) related to laboratory environment and system applications 
  • Knowledge of 21 CFR Part 11
  • General understanding of QC Lab and manufacturing processes and laboratory analytical application/systems is a plus.
  • Effective problem-solving and analytical skills to resolve operational problems.
  • Excellent written and verbal communication skills.
  • Demonstrated Business Acumen.
  • Demonstrated learning agility.
  • Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
  • Strong collaboration with colleagues at all levels.
  • Demonstrated success in influencing without authority.
  • Strong customer service and teamwork oriented.
  • Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
  • Highly flexible, adapting to changes in priorities, requirements and processes is required.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-7545.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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