Lilly Production Specialist - Fermentation in Charlottetown, Prince Edward Island
Title Production Specialist - Fermentation
State / Province Prince Edward Island
Company Overview Elanco Animal Health, a division of Eli Lilly Canada Inc, is engaged in the discovery, development, manufacturing and marketing of innovative animal health products.
Elanco is a world leader in developing products and services that enhance animal health, wellness and performance. Elanco products contribute to the production of an affordable and abundant supply of food. Our half-century of innovative products, services and global partnerships help to fulfill our vision of food and companionship enriching life.
Responsibilities Position Description :
To produce 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 safety requirements, cGMP, SOP and manufacturing documentation.
Produce antigens in a timely manner according to their approved Outline of Production/Product Dossiers and to cGMP guidelines
Operate and maintain fermentation production equipment including, but not limited to, cleaning and sterilizing of fermenters, fermenter inoculation, solution preparation, collecting of samples, performing aseptic manipulations, maintaining production seed stocks
Manage and control fermentation process such as dissolved oxygen, temperature and product microbiological stability etc.
Write batch records and SOPs for the fermentation operations
Review batch documentation and check all calculations on a timely manner.
Participate in technology transfer of processes from R&D Process Development to Manufacturing.
Cross Train in other processes (when time permits) such as downstream processing to provide resources as needed.
Report any unexpected observations and suggest possible explanation and resolution.
Effectively investigate the events that happen during any fermentation batch failures by using root cause analysis tools
Provide leadership to peers on the floor by demonstrating knowledge, expertise and implementing process improvements
Calibrate and validate production equipment on time as per the validation schedule
Bachelor’s or Master’s Degree in a life sciences (e.g. Biochemistry, Chemistry, Chemical Engineering, Biology)
3-5 years of experience in the GMP bio manufacturing industry
Experience with Fermentation in a cGMP Manufacturing environment
Experience in the preparation of Standard Operating Procedures, preparation of batch records as per specific GMP requirements
Excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with Management, staff and other departments such as Quality Control and Quality Assurance.
Outlines of Production, cGMP guidelines, and HSE regulations
Experience performing investigations and writing deviations
Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point)
Additional Skills/Preferences Thorough technical understanding of quality systems and regulatory requirements
Must be able to work shift work (12 hour daytime shifts, 3-4 days/week including some weekends) and overtime as required
Must be able to wear clean room garments and remain in clean room area for up to 3 hour time period
Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.
Must be able to lift, move and maneuver small-medium sized equipment – up to 25lbs.
Requires ability to stand for long periods of time
Requires frequent ladder or stair climbing
Must be able to read, write, understand, and comply with appropriate standard operating procedures.
Elanco will conduct, at its own expense, background search (including verification of educational credentials, contacting three of your personal references) of the successful candidate.
Elanco is committed to employment equity. We encourage applications from qualified women, members of visible minorities, Aboriginal peoples, and persons with disabilities.
Please do not contact us via phone. We appreciate all who apply; however, only those candidates selected for an interview will be contacted.
Candidates must be legally eligible to work in Canada. Elanco Canada does not sponsor work permits or other employment visas.
Removal Date 15-May-2017