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.
Injectable Filling Operations Technician/Assistant is responsible for filling injectable drug product into primary containers. Work is performed in strict compliance with manufacturing standards (SOPs) and all regulatory requirements (i.e., GMPs). This job includes the following functions: aseptic gowning and personnel monitoring, processing of hazardous and non-hazardous drug products, basic computer skills and physical material handling. Colleagues are expected to share best practices with other colleagues on their shift, and across shifts.
Colleagues will be required to work in other areas, such as Freeze Dry, Inspection, or Packaging, as production demands require. Over-time and weekend work as production demands require
Specific job functions include:
• Setting up and changing over the filling lines per approved procedures
• Demonstrating ownership and accountability to production schedule and protecting product quality
• Monitoring filling line for efficient run time versus established standards
• Ensuring adequate inventory of parts and materials prior to initiating a production run
• Assisting maintenance in equipment troubleshooting
• Performing total productive maintenance/operator care tasks
• Identifying and seeking to implement process and safety improvements
• Executing in-process quality inspections
• Recording GMP entries in batch record
• Working as filling operator if required
• Following all safety procedures
• Cleaning and sanitizing filling lines per approved procedures
• Developing corrective and preventive actions
• Seeking value added tasks during unplanned line downtime
• Completing and maintaining all required training on time
• Act as trainer for other Operations Technicians/Operators
• Other duties as assigned by the supervisor
• Working inside the APA as scheduled
High school diploma / general education degree (GED) and 6 months related experience or military experience or an associate's degree. Demonstrated math and reading comprehension proficiency at level that meets "Role" and/or "test" requirements. Basic administrative and/or standardized, semi-skilled work routines; operation of non-complex technical and/or mechanical tools and equipment. Demonstrated interpersonal leadership and accountability in day-to-day interactions with an operational focus on customer needs and process requirements is required. Considerable demonstrated skills in communicating (oral and written) effectively with diverse individuals/groups; facilitating trust and understanding; and developing, influencing and managing work, employee and customer relationships.
Position involves extensive lifting, sitting, standing, walking, repetitive motion, flexibility, aseptic gowning, and routine weekend work.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Aseptic Gowning required.
Routine Weekend Work.
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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