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A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The incumbent will be knowledgeable of process equipment and systems, manufacturing operations, and automation control (PLC, Delta V, etc) and their primary responsibility will be to plan for and execute process and equipment operation activities during manufacturing operations. The incumbent will assist with production planning and provide / support coordinating production activities in Fermentation, Purification, and process support areas.
The incumbent will provide training for operational qualifications and assist the Shift Supervisor and Process Engineer in assuring all personnel are appropriately trained for the applicable tasks.
The incumbent provides process execution and equipment operational activities in support of cGMP manufacturing. Provides organizing role to ensure appropriate scheduling of activities and ensure production supplies are available for the day's operations. The incumbent works directly with the Supervisors and Process Engineers in the resolution of issues to fulfill manufacturing requirements during the shift of operation.
Conducts all activities that are in accordance with Company policies & SOPs, the company Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc. Advise management of non-conformance issues and opportunities for continuous improvement.
The incumbent is a skilled scientist with knowledge of microbial fermentation and/or purification and has experience with unit operations and control systems. The incumbent works as part of the production team and leads as well as performs scientific and operational tasks related to cGMP manufacturing. The incumbent will work in support of 24 hour operations - working in various shifts. Job responsibilities include:
• This position may act as production area specific shift lead working in a team environment to execute operational activities in support of manufacturing. Requires detailed knowledge of the operational aspects for Media/Fermentation, and/or Buffer Prep/Purification processing to organize and execute daily functions in a safe, compliant, and efficient manner to maintain production schedules. Must be able to make recommendations to changes in the schedule and to re-direct activities as necessary to minimize impact to quality, compliance and timelines.
• In addition to processing, cleaning, and operating major process equipment (tanks, fermentors, ultrafiltration units, centrifuges, column, etc.), job duties also include routine production preparation tasks such as preparing production glassware and other equipment by operating industrial washers and autoclaves, use calibrated scales to weigh out dry components and use graduated cylinders and flasks to measure liquids. Also, performs laboratory activities such as: performing sample dilutions, pH, and conductivity readings.
• Requires understanding of scientific principles, operational aspects of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on microbial fermentation / purification and conjugation processing.
• Capable of detecting technical problems and assisting the appropriate colleagues for resolution. Ability to collect and assemble applicable, vital information for presentation to supervisors and/or Process Engineers to assist in troubleshooting and decision making.
• Provides input and revises SOP's, batch records, forms or other cGMP related documents developed or revised to support continous improvement efforts, investigation corrective actions, manufacturing operations, automation control (PLC, DeltaV, etc.) and regulatory audit commitments.
• This position will provide operational support for equipment verification activities as needed for facility preparation and start-up, as well as providing input for the creation/revision of operational procedures and master production records.
• May be required to attend meetings of major capital or process improvement teams, eg. Facility expansion, technology transfer, MES implementation, operational efficiency, etc.
• Requires understanding of continuous improvement (CI) processes. Ability to use CI boards and provide input. Knowledgeable with 5S process and have the ability to maintain 5S standards within the manufacturing areas.
BS degree with four to seven years of experience in a FDA regulated industry
Four to seven years of experience within the biopharmaceutical industry, including knowledge and experience with relevant biopharmaceutical unit operations and/or laboratory operations. Experience should include operational and troubleshooting skills for biopharmaceutical processing equipment and/or analytical instrumentation.
Applicable skills and qualifications to perform daily operational tasks and lead/assist with shift activity scheduling
Moderate repetitive standing, sitting, bending, ladder climbing, pushing and lifting (up to 40lbs) required on a daily basis.
Ability to perform mathematical calculations and learn new processes.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be able to work a rotating shift schedule to support a 24 hour manufacturing operation.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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