- Responsibilities:
- Manage the site's calibration program
- Supervise a team of calibration technicians to ensure 24/7 site coverage
- Handle vendor calibration documents and related investigations
- Conduct corrective and preventive maintenance calibrations on GMP & non-GMP equipment
- Support overall site calibration processes including resource management, conflict resolution, scheduling, and proactive planning
- Perform instrument out of tolerance investigations
- Administer calibration-related training
- Complete necessary documentation to certify calibration per cGMP requirements
- Review and approve engineering project documentation
- Bachelor's degree in Engineering (ME, EE, Chem E) or equivalent work experience
- 3-5 years of experience in Pharmaceutical or Life Science Industries performing calibration duties
- Experience in a GMP/regulated environment
- Proficiency in business software programs such as Maximo, Microsoft Outlook, and Office Suite
- Experience with maintenance processes and Maximo CMMS or equivalent
- Excellent verbal and written communication skills
- Track record of providing exceptional customer service
- Ability to work independently efficiently
- Good documentation practices
- Commitment to maintaining a safe work environment
- Authorization to work in the United States
- Proficiency in business software programs such as Maximo, Microsoft Outlook, and Office Suite
- Effective teamwork skills
- Experience in a GMP/regulated environment
- Position: Day shift, Monday-Friday, 8 hours per day
- May need to respond to off-hour emergencies
- Overtime may be required during peak periods or for additional coverage
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Principal Engineer - Concord, United States - Lilly
Description
At Lilly, we bring together care with innovation to improve the quality of life for individuals worldwide. We are a leading global healthcare company based in Indianapolis, Indiana. Our dedicated team works tirelessly across the globe to develop groundbreaking medications, enhance disease understanding, and contribute to communities through charitable initiatives. Upholding our core values of Integrity, Excellence, and Respect for People, we prioritize human well-being in everything we do.
About Us:
At Lilly, we are on a mission to transform lives globally by creating, developing, and distributing medical solutions that promote longevity, well-being, and vitality. In addition to delivering revolutionary treatments, we are committed to fostering community support through philanthropy and volunteer efforts.
Lilly blends compassion with innovation to produce medications that enhance lives around the world. As a long-standing Fortune 500 company with over 140 years of operation, we prioritize safety and quality in every medical creation while upholding our values of Honesty, Quality, and People-Centricity.
Lilly is in the process of constructing an advanced Parenteral, Device Assembly, and Packaging Facility in Concord, North Carolina. This presents a thrilling opportunity to contribute to the establishment and management of a cutting-edge production site and Quality System from the ground up.
We are searching for a skilled and experienced professional to join our team as an Instrumentation Engineer. The selected candidate will supervise calibration and measurement operations for a cGMP manufacturing facility, overseeing calibration SOPs and related documentation.
Basic Requirements:
Additional Skills/Preferences:
Additional Information:
This job description aims to provide a general overview of the role requirements at the time of its drafting. Job responsibilities may evolve over time, encompassing additional duties not explicitly outlined in this description. For GMP compliance, the job specifications must be updated for significant changes. It is advisable to consult your supervisor regarding your specific job responsibilities and any other associated duties.
Eli Lilly and Company, Lilly USA, LLC, and our subsidiaries are dedicated to facilitating the participation of individuals with disabilities in the workforce, ensuring equal job opportunities. If you require accommodation to apply for a position at Lilly, please contact Lilly Human Resources for assistance. Note that the provided email address is exclusively for requesting application-related accommodations and will not address other inquiries.
Lilly upholds EEO/Affirmative Action principles and refrains from discriminating based on age, race, religion, gender, sexual orientation, identity, expression, national origin, veteran status, disability, or other protected statuses.
Our employee resource groups (ERGs) provide robust support networks and aid in nurturing talented individuals for future leadership roles. Existing groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network, Lilly India Network, Organization of Latinos at Lilly, PRIDE, Veterans Leadership Network, Women's Network, Working and Living with Disabilities.
