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- Boston, MA
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MANUFACTURING TECHNICIAN IV (Boston00038)
Fresenius Kabi • Boston, MA
Posted 12 days ago
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About Fresenius Kabi
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.
The Manufacturing Technician IV is a highly qualified, experienced technician/operator in the preparation of sterile products from a cGMP and/or pharmacy compounding background. Candidates will possess a high level of attention to detail and experience with various methods of compounding and cGMP manufacturing The employee will be responsible for gowning to the required standard. Manufacturing Technicians are responsible for following all relevant departmental SOPs and Master Formulation worksheets of each batch. Responsible for set-up, operation and monitoring of various devices per Standard Operating Procedures. Maintains equipment, parts and supply inventory.
- Production Compounding
- Quality Control
- Knowledge and Compliance
- Continuous Improvement
- Maintenance of clean room equipment
- Ability to trouble shoot problems
- Assumes other duties and responsibilities as directed by supervision
- Ability to modify SOPs and assist with Deviation investigation/resolution
- Ability to train new technicians
- Perform manufacturing processes with minimal supervision.
- Provide direction to less experienced personnel when necessary.
- Maintain orderliness of production area.
Calibration, operation and monitoring of devices required per Standard Operating Procedures.
- Follow with strict adherence all relevant SOPs, cGMPs, batch records and other controlling documentation when performing activities.
- Understands and maintains production schedule.
- Maintains orderliness of production areas.
- Be able to complete periods of standing or twist and lift activities during job shift.
- Complete area sanitizations and housekeeping.
- Be able to learn and be competent in other core skills related to department. Not all cores skills are required.
- Follows SOP’s pertaining to staging/preparing/transport. Address and report to Manager any problems in daily manufacturing and propose effective countermeasures.
- Ability to receive and maintain high level gown qualification.
- Technical comprehension of mechanical functions and controls of various machinery.
- Maintains and understands aseptic manufacturing principles related to compounding of sterile products.
- Cleans equipment per SOPs and cGMPs.
- Works in time efficient manner while maintaining adherence to all applicable SOPs.
- Maintains inventory of production supplies.
- Oversees cleaning of compounding suites.
- Complete documentation clearly and concisely.
- Assumes other duties as assigned.
- Assist in the training of new employees and completes training on procedures in scheduled time frame.
- Comprehend and troubleshoot various equipment within the controlled area.
- Report any faulty devices and products.
- Take bioburden samples.
- Complete paperwork on samples, logbooks or electronic records.
- Perform product sampling and environmental monitoring per Standard Operating Procedures.
- Ensure cabinets and rooms are operating as required, alerting management if any deviation occurs.
- Assists in auditing all equipment and systems used in compounding area.
- Participates in continuous quality improvement.
- Contribute improvement ideas and suggestions.
- Attend workshops as required.
- Completion of all required documentation per order.
- Interacts with other elements of business such as QA, QC, Materials
- Participate in meetings as needed.
- Ensure execution of all duties assigned to personnel in production suite.
Knowledge and Compliance
- Maintain a current and comprehensive knowledge of relevant procedures and policies.
- Compliance with relevant Acts, legal demands, code of conduct and ethical standards.
- Bachelor’s degree in scientific discipline or appropriate combination of education, training and experience.
- 7 to 10 years’ experience in aseptic filling environment required.
- Experience operating various automated compounding devices.
- Mechanical aptitude required.
- Formal Training in GMP, 503B and Quality Systems (would be preferred).
- Mechanical aptitude required.
- Quality minded and detail oriented.
- Excellent attendance and punctuality.
- Ability to stand for 6 hours in a production suite.
- Advanced computer skills.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, and 401K with company match.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.