Advisor QA Next Gen MES

Job description

JOB DESCRIPTION

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 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.

At Lilly, we serve an extraordinary purpose.

For more than 140 years, we have worked tirelessly to discover medicines that make life better.

These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

Responsibilities

The QA Advisor, Next Gen MES, will support the evaluation and implementation of innovative manufacturing process automation and IT systems, with a primary focus on Lilly’s deployment of a next-generation Manufacturing Execution System (MES).

Serving as a business subject matter expert (SME), this role will represent Quality Assurance (QA) throughout the project.

The primary responsibility of this role is to partner with the Next Gen MES team to evaluate, design, and deploy the new MES across Lilly’s parenteral manufacturing network.

The QA Advisor will serve as the QA representative on the project, acting as a core team member within the MES Center of Excellence and ensuring alignment with existing process automation systems.

The Center of Excellence is tasked with delivering a globally validated IT platform that can be deployed across manufacturing sites worldwide, while driving standardization and process optimization

Additionally, this role will support the final disposition of semi-finished and/or finished drug products and provide guidance to sites on batch-related issues, including non-conformance investigations, issue resolution, and other batch disposition activities.

The QA Advisor will serve as a technical leader within Quality to ensure adherence to global and local quality requirements.

Key Objectives/Deliverables:

• Work safely and proactively seek opportunities to improve both personnel and equipment safety.
• Serve as a core member of the Next Gen MES Center of Excellence and act as the lead for decision-making within the QA function.
• Influence and maintain a strong understanding of quality requirements across all supported sites, serving as an escalation point for QA issues.
• Identify opportunities for standardization and develop harmonized processes where appropriate to support network-wide alignment.
• Define and provide business requirements, acting as an ambassador for the Next Gen MES program and serving as the QA SME on system capabilities.
• Represent QA in design governance discussions and support site deployment teams.
• Bring an innovation-focused mindset, combined with deep knowledge of business objectives, manufacturing and quality processes, technologies, and IT/automation infrastructure, to help define the future-state vision for manufacturing.
• Support batch disposition for semi-finished and/or finished drug product batches) to ensure timely market release of Lilly medicines to patients.
• Lead, mentor, and coach site personnel on quality topics related to MES and batch disposition processes.
• Provide guidance to operational teams to ensure robust quality systems and ongoing GMP compliance.
• Participate in self-led inspections and support internal and external regulatory inspections as needed.
• Effectively review and approve MES-related GMP documents, including deviations, procedures, protocols, reports, specifications, and change controls, to ensure quality requirements are met.

Basic Qualifications

Examples of Basic Qualifications

• Education: minimum educational requirement to perform the position

Bachelor Of Science Degree in Engineering or a Related Science Field

• Experience: minimum specific experience required to perform the position.

Five years of pharmaceutical manufacturing experience with a minimum of 3 years working as MES subject matter expert (SME) including knowledge of Databases, Enterprise Systems, Process Automation Systems, Data Historians, and Manufacturing Execution Systems (Mes).

• Professional Certification/License: the professional certification/license required to perform the position.

Computer System Quality Assurance (CSQA)

• Assessment: indicate any required assessment for the position.

Successful completion of Pre-Employment Screening.

For internal candidates a minimum of “successful” performance ratings over the previous two years

Additional Skills/ Preferences

Examples of Additional Skills/Preferences:

• Ability to influence diverse groups and effectively manage relationships, leading without authority in a matrix structure.
• Candidates should be open to frequent travel (up to 40%)
• Knowledge related to ISE S95 and S88.
  
  Principles
  knowledge of Lilly’s preferred platforms, Including Rockwell Automation, SAP, Darwin, Osi Pi Data Historians and PMX.
• Experience With Mes Integration With Process Automation Systems
• Experience in root cause analysis, and batch release.
• Technical Writing And Communication Skills
• Demonstrated ability to lead in a matrixed or multi-site organization
• Change management experience and ability to drive adoption of new processes

Additional Information

Examples of Additional Information:

• Work across multiple time zones
• Perform duties in cleanroom environments, including full gowning as required
• Use of safety gear and adherence to site-specific safety requirements as needed

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (*******************************************************) for further assistance.

Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees.

Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).

Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The anticipated wage for this position is

$121,500 - $178,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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