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.
Drive & model behaviours in alignment with company principles with a particular emphasis on speaking up for safety & quality.
Demonstrates OE leadership - adheres to standard calendar including Huddles and Gemba’s.
Facilitates the daily huddle meeting – ensures cross functional attendance, metrics delivery and action completion / accountability.
Provides daily update to Control tower on key issues, mitigations and schedule adherence.
Facilitates cross functional process team meetings – including routine balanced scorecard review, continuous improvement project prioritization and improvement delivery accountability.
Works with cross functional process team to deliver one schedule – including all production and maintenance activities.
Works with Supply chain to manage raw material issues / BOM improvements.
Holds routine 1:1’s with supervisor(s) – completes performance management and also development discussions.
Ensures that performance management / development discussions are completed for production technicians and process technicians.
Encourages recognition with team.
Leads significant Deviation investigations using structured root cause analysis tools - documents investigations in Trackwise.
Clearly communicates to whole process team.
Reviews revisions to batch records, SOPs, qualification documents for the production operations.
Implements small operational changes – writes change controls as required, ensuring compliance to procedure.
Provides input to URS documents for key capital projects.
Acts as production lead for capex projects – ensuring operational readiness plan is defined and completed on time.
Escalates significant issues and potential solutions to the production manager.
Must have a Bachelor’s Degree in a life sciences (e.g. Biochemistry, Chemistry, Chemical Engineering, biochemical engineering, Biology).
5-10 years of experience in the GMP bio manufacturing industry
3-5 years 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 all levels.
Thorough technical understanding of quality systems and regulatory requirements
Lean or Six sigma experience
This role will be located at 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.