QC Microbiology Equipment-FDE

Employer
Lilly
Location
Indianapolis, Indiana, US
Salary
Competitive
Posted
Jul 28, 2021
Closes
Aug 04, 2021
Ref
2345517331
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
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.
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 39,000 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. #WeAreLilly
Position Brand Description:
To provide equipment lifecycle management support to the Parenteral QCL. Main support functions include specifying and purchasing equipment; authoring EQ and Computer System Validation (CSV) packages, managing the EQ and CSV processes, and providing daily operational support of laboratory equipment by ensuring the equipment is maintained in a qualified state of compliance. The position requires an understanding of corporate quality systems, a detail oriented quality mindset with an understanding of analytical/micro laboratory equipment, knowledge of lab methods to understand intended use of equipment and their failure modes effects. High-quality skills to include: equipment troubleshooting, ability to prioritize, written and oral communication, decision making, interpersonal/people, computer applications, problem solving.
Key Objectives/Deliverables:
- Author equipment qualification/validation protocols for the QCL.
- Technical review and execution of qualification/validation protocols.
- Recommend and specify equipment purchases based on user requirements.
- Communicate with other functions and external vendors regarding qualification, maintenance issues, and key operational objectives.
- Act as liaison between the building scheduler, maintenance shops and lab personnel to schedule preventative and corrective maintenance of equipment.
- Responsible for design and execution of laboratory CSV initiatives and deliverables, System Security Administrator duties, system upgrades, and data integrity.
- Apply knowledge of quality principles, GMPs, federal regulations, corporate standards and practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management.
- Interact effectively with customers, support groups and development.
- Network with other areas to understand best practices, share knowledge, participate in global meetings and web seminars, and to ensure customer needs are met.
- Influence improvements and streamline quality systems relating to equipment.
- Serve as equipment expert and technical resource in the review of technical documents.
- Act as subject matter experts and originator of change controls.
- Originate and investigate TrackWise CAPA records.
- Interact with Global Quality Lab Equipment function to set global corporate policy regarding equipment.
- Ability to multitask, prioritize and coordinate work to meet customers needs.
- Demonstrate problem solving and investigative skills.
- Ability to make decisions based on knowledge, experience, best practices and requirements.
- Ability to work independently and accurately with minimal supervision.
Additional Preferences:
- At least 5 years laboratory experience in QC or development lab with emphasis on laboratory equipment.
- At least 3 years providing substantial support for equipment and/or systems in a in a GMP environment
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
- Working knowledge of CMMS, SmartLab, Empower, TrackWise, Regulus
Education Requirements:
- Bachelor degree in scientific field related to the lab (Chemistry/Biology/Microbiology/Engineering) or 5-7 years of laboratory experience with emphasis on laboratory equipment
Other Information:
- This position is not permanent. It is for a fixed term position up to a maximum of 4 years.
- Ability to work 8 hour days - Monday through Friday
- Ability to work overtime as required.
- Ability to carry cell phone off shift and respond to operational issues as required.
- Minimal travel required.
- 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 position.
Eli 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 ( LillyRecruitingCompliance@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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.? We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
#WeAreLilly