LabVantage Deployment Specialist

BioSpace; Indianapolis (IN); On-site; USD 63,000 - 162,800; Full time

Benefits offered by this job

401(k)

Pension

Health benefits

Flexible benefits

Life insurance

Paid time off

Well-being programs

Job summary

A global healthcare company in Indianapolis seeks a LabVantage Deployment Specialist. The role involves overseeing LabVantage implementation at sites, ensuring compliance with GMP requirements, and providing ongoing support. Candidates should possess a bachelor's degree and a strong background in laboratory operations. This position offers competitive compensation with a range of $63,000 - $162,800, along with potential bonuses and comprehensive benefits.

Responsibilities

• Lead the sites on the implementation of LabVantage through the different phases of deployment.
• Act as SME in QA, QC Lab, or Stability.
• Assist sites during data discovery to identify master data elements.
• Evaluate feasibility and global impact of site change requests.
• Work with project manager to identify and report key process indicators.
• Collaborate with and manage third-party partners.
• Ensure LabVantage processes are compliant with data integrity and GMP requirements.
• Understand local requirements and communicate changes to promote adoption.
• Provide ongoing support and issue resolution for LabVantage.
• Raise issues to the Site Council and/or LabVantage leadership team.
• Share best practices to promote transferable processes.
• Provide answers during inspections and audits.

Skills

Experience working in/with GMP laboratories

Strong scientific background

Clear understanding of quality laboratory issues and activities

Experience in defining and improving business processes

Knowledge of cGMP and quality systems

Solid understanding of GMP requirements and data integrity principles

Proven ability to work with computer systems and adapt them to business processes

Knowledge of product release processes

Experience managing stability programs

Ability to manage multiple priorities simultaneously

Education

Bachelor's degree

Bachelor's degree in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related field

Job description

Overview

Join to apply for the LabVantage Deployment Specialist role at Lilly. The LabVantage Deployment Specialist is part of a team of informatics professionals who work closely with Tech@Lilly (IT) to deploy, maintain, and ensure compliance of the LabVantage application throughout its lifecycle. They represent the needs of the business areas they support and act as their voice and advocate.

Lilly is a global healthcare leader dedicated to discovering and bringing life-changing medicines to people around the world, headquartered in Indianapolis, Indiana.

Responsibilities

• Site deployment: Lead the sites on the implementation of LabVantage through the different phases of deployment. Maintain deployment documentation, including site readiness checklists, issue logs, and lessons learned.
• LabVantage Domain Expert: Instruct on the to-be processes in LabVantage (e.g., sample management, batch release, stability, lab execution). Act as a SME in QA, QC Lab, or Stability.
• Data Discovery Assistance: Assist sites during data discovery to identify the scope and the master data elements that need to be created as part of the LabVantage deployment.
• Change Management: Triage site change requests, evaluate feasibility and global impact. Prioritize requests according to site needs.
• Key Process Indicators: Work with the project manager to identify and report key process indicators to track deployment progress.
• Third-Party Management: Collaborate with and manage third-party partners to support LabVantage deployment.
• Compliance: Ensure LabVantage processes are compliant with data integrity and GMP requirements in coordination with the Global LabVantage team.
• Global Process Standardization: Understand local requirements and apply them to standardized global processes. Communicate changes to sites and promote adoption of globally standardized processes and tools.
• Support Team Engagement and Issue Resolution: Provide ongoing support and issue resolution for LabVantage business processes. Escalate software gaps or required business process changes to support deployment.
• Issues escalation: Raise issues to the Site Council and/or LabVantage leadership team.
• Coaching and mentoring: Share best practices to increase system knowledge and promote transferable processes between sites.
• Inspection Support: Provide answers to questions from inspections, audits, and other assessments affecting globally owned applications and their workflows.
• System Release Support: Support system releases by enabling UAT and updating affected procedures.
• Master Data Support: Act as an extended master data support when required by the master data workstream.

Minimum Requirements

• Bachelor’s degree
• Minimum 3 years of laboratory experience

Education Preference

• Bachelor’s degree in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related field

Skills

• Experience working in/with GMP laboratories
• Strong scientific background
• Clear understanding of quality laboratory issues and activities
• Experience in defining and improving business processes
• Knowledge of cGMP and quality systems
• Solid understanding of GMP requirements and data integrity principles
• Proven ability to work with computer systems and adapt them to business processes; extensive knowledge of analytical methods, laboratory documentation, and control processes
• Knowledge of product release processes
• Experience managing stability programs
• Ability to manage multiple priorities simultaneously

Additional Information

• This position requires occasional travel to manufacturing sites, development laboratories, and application vendors. Willingness to visit laboratories and manufacturing sites with PPE and gowning requirements.
• Role is primarily on-site, with limited flexibility to work from home
• Location posted as Indianapolis but open to other Lilly manufacturing sites

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly is 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 members and are open to all employees. Compensation will depend on education, experience, and location. The anticipated wage is $63,000 - $162,800. Full-time employees may be eligible for a company bonus and a comprehensive benefits program, including 401(k), pension, health benefits, flexible benefits, life insurance, paid time off, and well-being programs.