Logo of Huzzle

Home

Matches

Explore

Manage

Associate - Operations Support

image

Lilly

17d ago

  • Job
    Full-time
    Mid Level
  • Engineering
  • Limerick

AI generated summary

  • You need 3+ years in biotech ops, project management skills, effective communication, cGMP knowledge, MS Office and SAP proficiency, strong organization, customer focus, and independence.
  • You will coordinate resources, ensure compliance, manage training, create procedures, and support operations and logistics during the plant start-up while liaising with vendors and executing protocols.

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.
  • Ability to communicate effectively to various audiences.
  • Ability to influence and network with multiple levels and functions of 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.
  • Strong organizational skills – ability to handle/prioritise multiple projects and requests.
  • Able to manage linked activities with rapid flow of integrated information.
  • Strong sense of customer focus and teamwork.
  • Ability to work independently and without direct supervision.
  • Language: English
  • Familiarity or expertise in SAP
  • Biotech Operations Experience
  • GMP Operations Experience
  • Third Level Qualification or equivalent education / relevant experience.
  • No certifications required.
  • Tasks require entering manufacturing areas which require wearing appropriate PPE.

Responsibilities

  • Ensure all activities are conducted following all HSE and GMP requirements.
  • Work closely with the Leadership to coordinate necessary resources to support activities throughout the duration of the start-up.
  • Escalate issues to the appropriate management level when necessary.
  • Work with functional leadership to organize, prioritize, and deliver on start-up initiatives to adhere to project milestones.
  • Establish framework for operations activities
  • Write procedures so that all operations activities are consistently executed.
  • Serve as an integrator to ensure all necessary activities in each phase of start-up are well planned and executed.
  • Participate in or lead efforts associated with the Training Quality system to help define the overarching training strategy.
  • Participate in or lead the design, development, and implementation of Biotech operations training through multiple waves of new hires and multiple phases of the project.
  • Participate in or lead the content creation and delivery of training materials through multiple waves of new hires and multiple phases of the project.
  • Assist with on-boarding operations staff throughout the duration of the project.
  • Work with Supply Chain personnel and Logistics Center to develop business process associated with Planning and Scheduling operations activities throughout the duration of the plant start-up.
  • Participate in or lead efforts to design and generate facility/process procedures and work instructions, electronic Batch Records, Logbooks, various training documentation, all start-up protocols (C&Q, PQ, PV, etc).
  • Liaising with vendors for equipment, services, and consumables to ensure all necessary equipment and vendors are appropriately qualified for the various phases of the project execution.
  • Support protocol executions throughout all phases of the project.

FAQs

What is the primary focus of the Operations Support Associate role at Lilly?

The primary focus is to provide technical and operational support to facilitate the start-up activities of the new Biotech Drug Substance Manufacturing Facility in Limerick, Ireland.

What are the essential qualifications required for this position?

A minimum of 3 years of biotech manufacturing-related experience, demonstrated project management skills, effective communication abilities, proficiency in MS Office, and familiarity with cGMPs are essential qualifications for this role.

Is experience in biotech operations necessary for this position?

Yes, having biotech operations experience is preferred, as it is relevant to the tasks and responsibilities associated with this role.

What tasks will the Operations Support Associate be responsible for?

Responsibilities include ensuring compliance with HSE and GMP requirements, coordinating resources, writing procedures, developing training materials, liaising with vendors, and supporting protocol executions throughout the project phases.

What is the education requirement for this position?

A Third Level Qualification or equivalent education/relevant experience is required for this position.

Will the Operations Support Associate need to work independently?

Yes, the successful candidate should have the ability to work independently and without direct supervision.

Is there a specific software proficiency expected for this role?

Yes, proficiency in MS Office applications and training database administration is expected, and familiarity or expertise in SAP is preferred.

Are there any specific health and safety requirements for the role?

Yes, all activities must be conducted following HSE and GMP requirements, and tasks may involve entering manufacturing areas, which will require wearing appropriate PPE.

How does Lilly view diversity and inclusion in the workplace?

Lilly is committed to creating an inclusive environment and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

Will training be provided for this position?

Yes, the Operations Support Associate will participate in or lead efforts to define and implement training strategies for operations staff throughout the duration of the project.

Lilly

We're a medicine company turning science into healing to make life better for people around the world.

Manufacturing & Electronics
Industry
10,001+
Employees
1876
Founded Year

Mission & Purpose

Eli Lilly and Company is a global pharmaceutical firm dedicated to discovering, developing, and delivering innovative medicines that improve patient outcomes worldwide. Their ultimate mission is to make life better for people around the globe through high-quality healthcare solutions. The purpose of the company is to create medicines that help people live longer, healthier, and more active lives, while maintaining a commitment to ethical standards, scientific excellence, and integrity in all their operations.