Engineer - Metrologist/Calibration

Lilly • Indianapolis, IN

5d

About The Position

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.
Responsibilities
Work in the GFM&ES Corporate Standards Laboratory implementing calibration standards for a variety of equipment and instrumentation used throughout Lilly. This position will guide and consult with CSL Metrologists and business partners in setting appropriate process measurement ranges, tolerances, and instrument PM frequencies in support of traceability and general measurement assurance objectives. This will include working with site area equipment owners to assist with proper equipment selection and leveraging technical influence to advance measurement science, calibration technology, instrument standardization and data integrity, calibration education and compliance with a global focus
This position will influence calibration discipline design, implementation and sustainment at the local site/network and global level through technical input leveraging internal and external knowledge.
This position will influence local and sites/network leadership to impact measurement science decision making through Tech presentations, Lab Tours, participation on focus teams, etc.
This position has influence over CSL and customer personnel.
Own and update Procedures, job plans, and data sheets impacting CSL calibration including
With QA, apply risk management to lab issues, assess overall lab risk and mitigation strategies. Own the completion of resulting Quality Plan item completions.
Represent the CSL during audits and resolution of customer issues.
Point of contact for interactions with US and OUS Sites on discipline specific calibration issues
Mentor - Coach technicians, provide technical oversight over specific disciplines support of business objectives.
Primarily Responsible, with QA, to help assess the seriousness of 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 future departures including overall implementation and frequency of intermediate checks of primary standards.
Responsible for meeting all local, corporate, and federal quality requirements.
Coordinate with Systems CSQA and DI Data Leader on procedures and systems requirements including System data assessments and reviews and systems remediation.
Responsible for meeting GQS and LQP systems requirements.
Coordinate overall participation in inter-laboratory comparisons for responsible disciplines where applicable and address any discrepancies found in analyzed results.
Develop and approve calibration and PM processes on a variety of laboratory and production equipment.
Direct the technicians on proper procedure execution.
Daily assess and cease any non-compliant work (work closely in conjunction with the CSL Lead Metrologist).
Create and Conduct metrology training for engineers, craft personnel, and other technical personnel including QEPs.
Supervise execution of calibration tests and second person verifies results obtained.
Convey needed resources to CSL Manager - Engineering.
Use appropriate methods, both temporary (hand changes) and permanent (change control) to change, review, and approve documents.
Direct quality concerns to Quality Assurance.
Consult with customers relative to their metrology needs, especially on compliance issues and investigations.

Requirements

• Bachelor's degree (4 yr. college) in engineering, science, or statistics,
• 2 or more years' experience in metrology or calibration role
• Demonstrated ability to perform engineering math functions.
• Ability to manage a high workload effectively and efficiently with prioritization to deliver compliance related work items on time.
• Demonstrated interpersonal skill.
• Demonstrated strong oral and written communication skills.
• Sustained first principles-based contributions
• Demonstrated capability to efficiently implement complex technical changes in support of CSL business objectives
• Demonstrated ability to resolve issues through data driven decision making
• Demonstrated ability to apply risk management to complex lab issues
• Proficient with computer systems including Microsoft Office products, VEEVA, eMail systems, and CMMS System.
• Knowledge of NIST and NCSLI practices and procedures.
• Knowledge of ISO17025

Nice To Haves

• Pharmaceutical, biotech, food, or specialty chemical industry experience preferred.
• Management/Oversight of External Service Provider calibrations
• Experience with Uv/Vis systems

Responsibilities

• Work in the GFM&ES Corporate Standards Laboratory implementing calibration standards for a variety of equipment and instrumentation used throughout Lilly.
• Guide and consult with CSL Metrologists and business partners in setting appropriate process measurement ranges, tolerances, and instrument PM frequencies in support of traceability and general measurement assurance objectives.
• Work with site area equipment owners to assist with proper equipment selection and leveraging technical influence to advance measurement science, calibration technology, instrument standardization and data integrity, calibration education and compliance with a global focus
• Influence calibration discipline design, implementation and sustainment at the local site/network and global level through technical input leveraging internal and external knowledge.
• Influence local and sites/network leadership to impact measurement science decision making through Tech presentations, Lab Tours, participation on focus teams, etc.
• Own and update Procedures, job plans, and data sheets impacting CSL calibration including
• With QA, apply risk management to lab issues, assess overall lab risk and mitigation strategies.
• Own the completion of resulting Quality Plan item completions.
• Represent the CSL during audits and resolution of customer issues.
• Point of contact for interactions with US and OUS Sites on discipline specific calibration issues
• Mentor - Coach technicians, provide technical oversight over specific disciplines support of business objectives.
• Primarily Responsible, with QA, to help assess the seriousness of 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 future departures including overall implementation and frequency of intermediate checks of primary standards.
• Responsible for meeting all local, corporate, and federal quality requirements.
• Coordinate with Systems CSQA and DI Data Leader on procedures and systems requirements including System data assessments and reviews and systems remediation.
• Responsible for meeting GQS and LQP systems requirements.
• Coordinate overall participation in inter-laboratory comparisons for responsible disciplines where applicable and address any discrepancies found in analyzed results.
• Develop and approve calibration and PM processes on a variety of laboratory and production equipment.
• Direct the technicians on proper procedure execution.
• Daily assess and cease any non-compliant work (work closely in conjunction with the CSL Lead Metrologist).
• Create and Conduct metrology training for engineers, craft personnel, and other technical personnel including QEPs.
• Supervise execution of calibration tests and second person verifies results obtained.
• Convey needed resources to CSL Manager - Engineering.
• Use appropriate methods, both temporary (hand changes) and permanent (change control) to change, review, and approve documents.
• Direct quality concerns to Quality Assurance.
• Consult with customers relative to their metrology needs, especially on compliance issues and investigations.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees