- Manages the site calibration program
- Oversee a team of calibrations technicians to provide 24/7 site coverage.
- Processes vendor calibration related documents and vendor calibration deviation investigations
- Maintains and performs corrective, preventative maintenance calibrations on GMP & non-GMP equipment
- Supports overall site calibration processes to include resource leveling, conflict resolution, scheduling, and proactive planning
- Conducts instrument out of tolerance investigations
- Oversees and administers calibration related training
- Completes required documentation to certify the verification and calibration per cGMP (current good manufacturing practices) requirements
- Review and approval of engineering project documentation
- Education Requirements: Bachelor's degree in Engineering (prefer ME, EE, Chem E) (or equivalent work experience).
- 3-5 years of related experience in Pharmaceutical, or other Life Science Industries performing calibrations duties..
- Experience working in a GMP/regulated environment
- Must be able to effectively use business software programs, such as, Maximo, Microsoft Outlook, Microsoft Office Suite and other required software programs.
- Experience in maintenance business processes and Maximo CMMS or equivalent.
- Excellent verbal and written communications skills.
- Demonstrated experience in providing a high level of customer service
- Successful candidate will frequently work independently and, as such, must be a self-starter and capable of working with minimal daily direct supervision.
- Good documentation practices
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
- Qualified candidates must be legally authorized to be 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
- Must be able to effectively use business software programs, such as, Maximo, Microsoft Outlook, Microsoft Office Suite, and other required software programs.
- Must be able to effectively work in a team environment.
- Experience working in a GMP/regulated environment
- This position is for day shift, M-F, 8 hours
- May be required to respond to off-hour call-in and emergencies.
- May require overtime during peak periods or when additional coverage is required.
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Principal Engineer - Concord, United States - Lilly
Description
We're looking for people who are determined to make life better for people around the world.
Organizational Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe 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.
Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.
Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up.
We are looking for a talented, experienced individual to join our company as an Instrumentation Engineer. The Instrumentation Engineer will oversee calibrations and measurements operations for cGMP manufacturing facility; manages calibration SOPs and all associated documentation.
Responsibilities:
Basic Requirements:
Additional Skills/Preferences:
Additional Information:
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
