Operations Support Specialist

5 days ago

Limerick, Limerick, Ireland Eli Lilly and Company Full time

At Eli Lilly and Company, we strive to make life better for people around the world by discovering and developing innovative medicines. Our employees work together to drive progress in healthcare, and we're looking for talented individuals who share our passion.

We're currently constructing a cutting-edge biotech drug substance manufacturing facility in Limerick, Ireland, which will be our most technically advanced site yet. This project requires several operational support roles to ensure its successful start-up, including planning, coordination, and technical expertise.

The Operations Support Associate will collaborate with various teams, including Operations Process Teams, Functional Support personnel, Project Leads, and others to provide technical and operational assistance. This role involves working closely with stakeholders to coordinate resources, prioritize tasks, and escalate issues when necessary.

Key Responsibilities:

  • Operations Support:
    • Ensure all activities adhere to HSE and GMP requirements.
    • Collaborate with Leadership to coordinate necessary resources for project milestones.
    • Elevate issues to management when necessary.
    • Work with functional leadership to organize, prioritize, and deliver on start-up initiatives.
    • Establish a framework for operations activities.
    • Create procedures to consistently execute operations activities.
    • Integrate efforts to ensure well-planned and executed activities throughout each phase of start-up.
    • Participate in or lead training quality system efforts to define the overarching training strategy.
    • Contribute to or lead the design, development, and implementation of Biotech operations training through multiple waves of new hires and project phases.
    • Assist with onboarding operations staff throughout the project duration.
    • Collaborate with Supply Chain personnel and Logistics Center to develop business processes associated with Planning and Scheduling operations activities.
    • Participate in or lead efforts to design and generate facility/process procedures, work instructions, electronic Batch Records, Logbooks, training documentation, and start-up protocols.
    • Liaise with vendors for equipment, services, and consumables to ensure qualification for project phases.
    • Support protocol executions throughout all project phases.

Requirements:

  • Minimum 3 years of biotech manufacturing-related experience, preferably some biosynthetic, fermentation, and/or purification operations experience.
  • Demonstrated skills in project management and coordination.
  • Effective communication skills to engage various audiences.
  • Influence and network with multiple levels and functions within the organization.
  • Proficient in MS Office applications and training database administration.
  • Familiarity with cGMPs and corporate policies and procedures.
  • Strong written and verbal communication skills.
  • Organizational skills to handle and prioritize multiple projects and requests.
  • Able to manage linked activities with rapid information flow.
  • Customer focus and teamwork.
  • Ability to work independently and without direct supervision.

Preferred Qualifications:

  • Language: English
  • Familiarity or expertise in SAP
  • Biotech Operations Experience
  • GMP Operations Experience

Education Requirements:

Third Level Qualification or equivalent education/relevant experience.

Additional Information:

  • No certifications required.
  • Tasks may involve entering manufacturing areas requiring PPE.

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