Validation Specialist
Company: Eli Lilly
Location: Fairland
Posted on: August 7, 2022
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 35,000 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. Organization Overview:For
140 years, Lilly has manufactured medicines that improve people's
lives around the world. We produce our medicines using some of the
most sophisticated manufacturing technologies and rigorous quality
standards. Lilly Manufacturing strives for excellence in its
process, standards, procedures and behaviors to develop medicines
with safety first and quality always. Responsibilities:Advanced
pharmaceutical manufacturing experience will be utilized to write,
develop and execute the implementation of local technical projects,
process improvement activities, and validation activities.Provide
support through the preparation and management of the technical
components of Change Controls, CAPA events, Manufacturing Tickets,
Validation Protocols, Standard Operating Procedures,
etc.Participate within cross-functional teams in a positive fashion
to execute validation activities and deliver business plan
objectives.Key Objectives/Deliverables:
- Write and execute validation protocols and summary reports
- Effectively work with operations/support groups to ensure
conformance to validation schedule
- Influence cross-functional process teams to drive technical
agenda items or improvement projects
- Ability to analyze and troubleshoot issues while executing
validation protocols
- GMP documentation of validation data
- Lead or support validation related investigations
- Perform gowning qualification and requalification (as
needed)
- Mentor operators and process team members on validation related
topics
- Identify, lead and implement projects driven from manufacturing
process teams or from local functional groups
- Utilize existing process monitoring software tools to collect,
monitor and, if necessary, notify management, Validation
Associates, and/or Technical Service Product Reps of adverse
trends
- Collection of data may include real-time routine data as well
as more specialized periodic process data (quarterly or
annual)Basic Qualifications
- High school diploma/GED
- Completion of Post Offer Exam, Completion of Work Simulation or
Completion of Administrative Skills Testing if applicable
- Experience in cleanroom control (including validation
requirements)
- Minimum of 5 years of direct cGMP pharmaceutical operations
experience
- Qualified candidates must be legally authorized to be employed
in the United States. Lilly does not anticipate providing
sponsorship for employment visa status (e.g., H-1B or TN status)
for this employment positionAdditional Skills/Preferences
- Responsible for maintaining a safe work environment, working
safely and accountable for supporting all corporate and site safety
goals
- Ability to effectively prioritize and carry out a variety of
tasks and requests related to validation
- Excellent written and oral communication
- Must have sufficient computer aptitude to learn the various
systems needed to support parenteral plant operations
- Demonstrated data collection and analysis skills
- Demonstrated ability to work independently
- Working knowledge of manufacturing operations
- Demonstrated leadership skills (i.e. proactive, assertive,
ability to positively influence others across multiple levels of
organization)
- Proficient Computer Skills in MS Word and/or MS Excel
- Demonstrated ability to effectively work in cross-functional
teams
- Demonstrated problem solving experience using scientific-based
methodologiesAdditional Information:
- 8 hour days Monday through Friday
- Overtime will be required as needed
- Required to carry cell phone and provide off shift coverage in
response to operational issues or validation activities
- Applicant will work in various areas within the Parenteral
Plant.Some allergens are present in the Parenteral Plant.Mobility
requirements and exposure to allergens should be considered when
applying for this positionEli Lilly and Company, Lilly USA, LLC and
our wholly owned subsidiaries (collectively "Lilly") are committed
to help individuals with disabilities to participate in the
workforce and ensure equal opportunity to compete for jobs. If you
require an accommodation to submit a resume for positions at Lilly,
please email Lilly Human Resources (
Lilly_Recruiting_Compliance@lists.lilly.com ) for further
assistance. Please note This email address is intended for use only
to request an accommodation as part of the application process. Any
other correspondence will not receive a response.Lilly 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. As a condition of
employment with Eli Lilly and Company and its subsidiaries in the
United States and Puerto Rico, you must be fully COVID-19
vaccinated and provide proof of vaccination satisfactory to the
company (subject to applicable law). #WeAreLillyRequired
Keywords: Eli Lilly, Indianapolis , Validation Specialist, Other , Fairland, Indiana
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