Metrologist/Calibration Engineer

Location Type: Not Specified

 

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. 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 business partners in setting appropriate measurement ranges, tolerances, uncertainties, and instrument PM frequencies for customers secondary standards. Position may be responsible for maintaining 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.

Key Objectives/Deliverables:

• 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.
• With QA, apply risk management to complex lab issues, with responsibility for final CSL assessment of overall lab risk and mitigation strategies. Own the completion of resulting Quality Plan item completions.
• 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.
• Coordinate with Systems CSQA and Data Integrity Site Leader on procedures and systems requirements including System data assessments and reviews, procedures gap assessments, participation in DI criticality assessment and systems remediation.
• 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 the Engineering manager.
• 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 deviation investigations.

Minimum Requirements:

• Bachelor’s degree (4 yr. college) in engineering, science, statistics, or a technical related degree OR equivalent experience in metrology (10+ years)
• Minimum 3-5 yrs experience in calibration/metrology
• Qualified candidates must be authorized to be legally 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 position.

Additional Preferences:

• Proficient with computer systems including Microsoft Office products, Trackwise/CAPA, eMail systems, and GMARS 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 skills.
• Demonstrated strong oral and written communication skills.

Other Information:

• 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.
• Regular shift days (M – F).
• Minimum travel (< 10% annually) will be required for training and/or vendor audits.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 – $167,200

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.

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.

#WeAreLilly