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 Operations Process Technician owns and drives the execution of Commercial and Clinical manufacturing according to Standard Operating Procedures and Production Schedule. The Process Technician will work on interdisciplinary self-directed teams, to define and implement process improvements, participate in process troubleshooting.
• Executes SOPs for unit operations (daily and long term). Includes CIP, SIP, and cleaning and sanitization of the facility.
• Operation of buffer/media tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying mixes of automation and paper SOPs involved.
• Supports implementation of new technology for process execution and/or analysis.
• Interacts across the asset to achieve production schedule.
• Reviews documentation daily as well as perform data entry - Monitor, identify and communicate process and compliance trends real time.
• Archives documentation according to established procedures.
• Required to modify and/or create job-related documentation including MBRs, SOPs, MFRs, work requests and others.
• Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
• Provides support during audits and with audit observation closure.
• Responsible for keeping training current.
• Maintains a safe working environment.
• Thorough understanding of cGMP requirements and safety practices.
• Employs Automated systems, enterprise systems, and available technology to execute work.
• Engages in and supports a culture of innovation and sustainable improvement through ownership of improvement for work processes, equipment and environment.
Strives for Right first time execution through flawless execution and ownership of the process.
High School diploma required. Associated Degree and manufacturing experience in a GMP or other regulated environment is preferred.
• Knowledgeable about how the organization works; knows how to get things done both through formal channels and the informal network; understands the origin and reasoning behind key policies, practices and procedures; understands the culture of the organization
• The ability to execute against SOP's and document entries in a cGMP compliant manner.
• Ability to interpret and prioritize workflow to maintain the production schedule.
• The incumbent is required to attain detail knowledge of the operational equipment
• The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing
• The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.
• Effective verbal and written communication skills.
• Requires the moving of heavy equipment and the ability to lift ~50 pounds
The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
1st shift, 6am -6pm, rotating
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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