Senior Associate

2 days ago

Lebanon, Pennsylvania, United States BioSpace, Inc. Full time
Job Details

At BioSpace, Inc., we are committed to making life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 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.

Job Overview

Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Responsibilities
  • Deliver on CSV processes and Data Integrity Sustainability
  • Establish and maintain CSQ support and DI sustainability processes.
  • Drive appropriate consistency in CSQ and DI controls.
  • Deliver Projects and Programs
  • Understand and maximize business value of Data integrity controls in computer systems.
  • Understand customer, company, and Quality priorities, and support implementation goals.
  • Provide consulting and right-sizing of DI activities for GMP computer systems based on risk and value.
  • Provide linkages to partner organizations with CSV and DI including Automation, Site C&Q, BQA, and other CSQA persons.
  • Grow Capabilities and Knowledge
  • Mentor others in DI and CSV-related roles
  • Grow capabilities of those performing DI CSV activities
  • Maintain Inspection Readiness
  • Provide consulting and interpretation on Corporate Computer Systems/Data Integrity standards and practices as implemented at the LP1 facility.
  • Provide cross-functional technical leadership in the event of serious quality-related issues with computer systems or data integrity.
  • Monitor current state of inspection-readiness.
  • Escalate issues appropriately.
  • Streamline and Continuously Improve
  • Promote common process and best practice across functions.
  • Identify systemic issues and trends across functions and drive improvement activity.
  • Understand the external environment/best practices and bring external learning back to Lilly.
Requirements
  • Bachelor's degree in Computer Science, Engineering, Mathematics, Life Sciences, or a technology-related field
  • 1+ year of experience in Automation/QC Labs/IT, Quality, or computer system validation in the pharmaceutical industry
  • Additional Preferences:
    • Direct experience with Computer Systems Validation (GAMP5) and data integrity basic principles (ALCOA+).
    • Previous experience in GMP or GLP environments
    • Demonstrated strong oral and written communication skills.
    • Strong interpersonal interaction skills
    • Proven ability to influence quality peers, IT SMEs, and upper management.
    • Previous experience in Business Quality Assurance and Automation
    • Understanding of process development and/or improvement (e.g. Six Sigma)
    • Knowledge of Lilly business area and its impact to products and patients
Additional Information

This is an on-site position in Lebanon, IN

BioSpace, Inc. 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

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