Expert Maintenance Technician, Calibration

6 months ago

Toronto, Canada Lilly Full time

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.

**About POINT Biopharma**:
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company.

**Position Summary**:
Reporting to the Director, QA/QC, the Senior Expert Maintenance Technician, Calibration will perform calibration, validation, and qualification activities on various types of equipment, including analytical instruments, laboratory equipment, and manufacturing equipment.

**Roles and Responsibilities of the Position**:

- Manage the calibration schedule, tracking system, and database to ensure timely and accurate calibration activities.
- Manage all equipment-related documentation to ensure equipment records are accurate and up to date at all times.
- Coordinate all equipment related to activities that involve external services.
- Develop and maintain calibration procedures, protocols, and documentation in accordance with regulatory requirements (e.g., FDA, ISO, cGMP).
- Conduct routine and non-routine inspections, troubleshooting, and repairs of equipment to ensure optimal performance and reliability.
- Collaborate with cross-functional teams including Quality Assurance, Manufacturing, and Engineering to support equipment qualification and validation efforts.
- Participate in new instrument requirement determination activities including but not limited to review of vendor IQ, OQ and PQ documentations.
- Participate in internal and external audits and inspections related to equipment calibration and metrology practices.
- Stay current with industry trends, best practices, and regulatory requirements related to metrology and calibration.

**Required Qualifications**:

- Bachelor degree in Engineering, Physics, Chemistry, Biochemistry, Biology, or related field.
- Minimum of 5 years of experience working in a metrology or calibration role within a regulated industry, preferably pharmaceuticals or biotechnology.
- Strong knowledge of metrology principles, calibration techniques, and instrumentation standards.
- Experience with FDA regulations, cGMP guidelines, and ISO standards related to equipment calibration and qualification.
- Proficiency in using calibration software and data management systems.

**Additional Preferences**:

- Certifications such as Certified Calibration Technician (CCT) or Certified Quality Technician (CQT) are preferred but not required.

**Physical Demands/Travel**:

- Must be able to work on your feet for an extended period of time.
- Must be able to perform tasks with dexterity to handle and operate machinery.
- Must be able to lift 10lbs. on a regular basis.
- The physical demands here are representative of those that must _be_ met _by an_ employee to_ successfully perform the essential functions of this job._

**Work Environment**:

- Position is required to be onsite downtown Toronto during the work week.
- This role works in a hospital setting and it is mandatory for all employees to complete health screens before onboarding. In the event the screen results show non-immunity, vaccines may need to be administered.
- The_ _work_ _environment_ _characteristics_ _descri_b_ed_ _here_ _are_ _representative_ of those an em_p_loyee encounters whil_e_ performing the essential _f_unctions of this job._
- _To perform this job successfully, an _individual_ must be able to perform_ the _role and responsibilities satisfactorily. The requirements _listed_ above are representative of the knowledge, skill, and/or ability _required._ Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions._

Lilly 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.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disa

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