Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
To support in the Production process of veterinary biologics according to a defined production schedule following cGMP guidelines and specific outlines of production to meet market demands for Aquaculture products.
Functions, Duties, Task:
- Comply with company Quality and safety standards, Adhere to safety first and quality always mindset.
- Ensures production operations comply with safety requirements, cGMP, SOP and manufacturing documentation
- Ensures the product produced according their approved Outline of Product/Product Dossiers and to cGMP guidelines in order to meet market demand for the Aqua products.
- Routine Shop floor presence ensuring that required standards are met in a timely manner.
- Drive & model behaviours in alignment with company principles with a particular emphasis on speaking up for safety & quality
- Provide leadership to team on the floor by demonstrating knowledge, expertise and implementing process improvements.
- Seen as facility owner by cross functional team – takes responsibility for all activities occurring in the area.
- Provides input to schedule and tracks adherence to it.
- Manages Team shift cover plan – including short term absences.
- Holds routine 1:1’s with production technicians and process associates – ensures development discussions held.
- Coaches, mentor’s & completed performance management for production technicians and process associates – holding accountable vs essential wins.
- Ensures team has robust training plan in place, tracks compliance to it and ensures operations are completed by trained competent people.
- Ensure that production equipment remains in an appropriate state of maintenance, calibration & validation. Liaise effectively with relevant support groups to ensure compliance.
- Batch documentation is completed accurately for each batch according to the outline of production.
- Batch Records reviewed and completed in a timely manner. Feedback provided to technicians to drive standards.
- Ensures timely completion of SAP related items including material consumption in production.
- Documents operational events and investigations in Trackwise- using structured root cause analysis tools.
- Clearly communicates to process team.
- Write and reviews revisions to production documentation for example autoclave qualifications, batch records and SOPs.
- Implements small operational changes – writes change controls as required, ensuring compliance to procedure.
- Provides input to URS documents for key capital projects.
- Escalates significant issues and potential solutions to process team leader.
- Updates the daily huddle board with assigned data ahead of the meeting.
- Facilitates daily huddle in absence of process team leader.
- Interviews for technician roles.
Basic Requirements/Education and Experience
- Must have a bachelor’s degree in a life science (e.g. Biochemistry, Chemistry, Chemical Engineering, biochemical engineering, Biology).
- 3-5 years of experience in the GMP bio manufacturing industry
- Previous Supervisory experience
- Experience performing investigations and writing deviations
- Experience in completing production documentation (i.e. deviations, SOPs, CAPAs, etc.).
- Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point), SAP and experience in Unicorn software is required
- Excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with Management and staff.
- Thorough technical understanding of quality systems and regulatory requirements
- Must be able to read, write, understand, and comply with appropriate standard operating procedures
- Position will be located in Charlottetown, PEI, Canada.
- Role will be available for contact 12 hrs a day 7 days a week for emergency situations.
- 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.
To apply, contact - firstname.lastname@example.org