About the company
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 engineer/ scientist in manufacturing operations is responsible for execution of the manufacturing process in a multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and development drug substance. Additional roles include using operational and technical knowledge to lead troubleshooting activities, support tech transfer and lead start-up activities, provide investigations support, analyze process data, and identify and implement process improvements.
• Execution of relevant process activities activities including protein purification (e.g. column chromatography and tangential flow filtration), solution formulation, and equipment preparation (set-up, CIP, SIP) by following established SOP's.
• Setup and evaluation of unit operations (daily and long-term)
• Process executions and changeover.
• Troubleshooting of process disturbances, identifying resolution and implementing corrective and preventive measures, as require
• Real time assessment of process performance.
• Individual will be required to perform process monitoring and data analysis, and data preparation for presentation in several forums including project team meetings. The successful candidate will ensure timely investigations of unexpected data and trends with the guidance of a people leader and/or group leader. Individual will assist in providing project updates through project meetings and seminars. After attaining a detailed knowledge of the operational equipment for each unit operation, individual will be required to solve routine technical problems associated with site assessment of specific unit operations used in biopharmaceutical manufacturing.
• Serve as the operations point of contact for technology transfer and start-up of products by reviewing process parameter tables, site assessments, review and approve plant documentation, change controls, process overview presentations, sampling plans, and other tech transfer deliverables
• Individual will provide subject matter expertise in supporting process and product related investigations, execute CAPAs and provide input to process and equipment change controls to ensure robust and capable solution.
• Individual will help to ensure the equipment and facilities are maintained in a GMP compliant state at all times.
• Individual is required to perform clear and concise documentation following relevant SOP's and electronic instructions. All documentation must be reviewed daily ensuring highest quality of documentation with identification and prevention of any process and compliance trends, as require.
• The individual will be assuming lead role in coordinating activities in absence of people leader and will be a primary skill trainer for the shift. Responsible for collaborating with other departments to communicate and coordinate activities.
• Individual is responsible for ensuring that the appropriate training is conducted and documented on relevant and departmental SOP's while providing critical input to the skill training module developments.
• Individual will assist in inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
• Individuals are responsible for modifying and/or creating job related documentation
• Individuals will be responsible for evaluation and implementation of new technology for process execution or analysis.
• Individuals will be expected to drive continuous improvement and innovation initiatives.
• Individuals are responsible to ensure a safe work environment.
• Individuals will be required to develop multi-tasking skills.
• A minimum of a BS in Engineering or life science with 2-6 years' experience in a biopharmaceutical environment is preferred.
• Knowledge of cGMP, cell separation operation with TFF and/or centrifugation, column purification /membrane based operations, and equipment IQ, OQ, PQ approaches are desirable.
• Previous experience with manufacturing-scale column chromatography and/or tangential flow filtration (UF/DF) a plus
• Qualifications include a willingness to work in a challenging environment that requires execution of new processes or stable processes. Mechanical aptitude is a plus, as many operations require manual intervention as well as use of automation.
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment.
• Effective verbal and written communication skills.
• Ability to work with intra and inter departmental functional areas fostering a collaborative teamwork environment is necessary.
Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
Must be able to lift ~50 pounds.
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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