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As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
Salary Range: The salary range for this position will be approximately $66,000 to $80,000 annually, which will be determined based on education and experience.
Position Description: 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, Tasks:
- 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 to their approved Outline of Product/Product Dossiers and to cGMP guidelines to meet market demand for the Aqua products.
- Routine shop floor presence ensuring that required standards are met in a timely manner.
- Drive and model behaviours in alignment with company principles with a particular emphasis on speaking up for safety and quality.
- Provide leadership to team on the floor by demonstrating knowledge, expertise and implementing process improvements.
- Seen as facility owner by cross functional team and 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 and ensures development discussions held.
- Coach, mentor and complete performance management for production technicians and process associates to drive accountability versus 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 and 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 Veeva using structured root cause analysis tools.
- Writes and reviews revisions to production documentation, for example autoclave qualifications, batch records and SOPs.
- Implements small operational changes including writing change controls as required and 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.
- Other duties as required.
Minimum Qualifications (education, experience and/or training, required certifications):
- 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 is preferred.
- 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.
- Thorough technical understanding of quality systems and regulatory requirements.
- Must be able to work 12-hour shifts (12-hour daytime shifts, 3-4 days/week including some weekends) and overtime as required.
- Role will be available for contact 12 hours a day 7 days a week for emergency situations.
- Must be able to read, write, understand, and comply with appropriate standard operating procedures.
Elanco 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