Lilly Calibration Engineer in Indianapolis, Indiana
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 serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Brand Description :
Work in a Pharmaceutical GMP NVLAP Accredited standards laboratory environment, implementing calibration standards on a variety of equipment and instrumentation used throughout Lilly laboratory and manufacturing operations. This position will guide and consult with customers in setting appropriate measurement ranges, tolerances, uncertainties, and instrument PM frequencies for over 500 annual PM‘s for customers secondary standards. Position will be responsible for maintaining 2 laboratories in a cGMP 21 CFR compliant state using validated equipment with trained personnel and in compliance with ALCOA+ principles for data integrity. This will also include working with area engineers to provide equipment selection during the equipment specification process.
Resources necessary to carry out duties and identify the occurrences of departures from the quality system or from the procedures for performing tests/ and or calibrations; initiate actions to prevent or minimize departures including intermediate checks of primary standards.
Responsible for meeting all local, corporate, and federal quality requirements.
Participate in inter-laboratory comparisons for responsible disciplines where applicable and address any discrepancies found in analyzed results.
Meet bi-annually with NVLAP Accreditation body to review, assess and update laboratory accreditations to comply with ISO 17025 requirements.
Develop and approve calibration and PM processes on a variety of laboratory and production equipment.
Direct the technicians on proper procedure execution.
Cease any non-compliant work (inform the Supervisor and Team Leader).
Conduct metrology training for engineers, craft personnel, and other technical personnel.
Provide guidance on regulations and standards issued from organizations such as NCSLI, NIST, FDA, USP, and ISO.
Supervise execution of calibration tests and second person verifies results obtained.
Assess external vendor technical qualifications to meet customer range and tolerance specification requirements. Audit vendors for conformance to ISO17025 requirements.
Determine appropriate corporate procedures required for consistent and accurate standards use.
Convey needed resources to Manager - Engineering
Use appropriate methods, both temporary (hand changes) and permanent (change control) to change, review, and approve documents.
Direct quality concerns to Lilly Quality Assurance.
Consult with customers relative to their metrology needs, especially on compliance issues and investigations.
Bachelor degree (4 yr. college) in engineering, science, statistics, or equivalent experience.
Minimum 3 yrs experience in calibration/Metrology.
Proficient with computer systems including Microsoft Office products, Trackwise/CAPA, eMail systems, and CMMS System.
Familiarity with Pressure and Vacuum instrument standards and calibration.
Knowledge of other calibration disciplines (Conductivity, Temperature, Electrical, Mass, UV Vis, Humidity, etc.)
Familiarity with Calibration System IQ, OQ and Software CSV and ability to install and qualify systems to meet customer user requirements.
Knowledge of NIST and NCSLI practices and procedures.
Knowledge of ISO17025 and Lab Accreditation processes
Pharmaceutical, biotech, food, or specialty chemical industry experience preferred.
Demonstrated ability to perform engineering math functions.
Demonstrated interpersonal skill.
Demonstrated strong oral and written communication skills.
Must be capable of working with a wide variety of people both internal and external to Eli Lilly and Company.
Expected to field incoming requests in a timely manner.
Shift days, M – F
Minimum travel (< 10% annually) will be required for training and/or vendor audits.
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.
As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
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!