Associate II, Manufacturing Operator (12 Hour Shift Every Other Wed, Every Thurs, Fri & Sat)
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Job Location:
Danbury, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases we develop and commercialize treatments that address serious unmet medical needs including diabetes pulmonary hypertension pulmonary fibrosis nontuberculous mycobacterial (NTM) lung disease and fluid overload associated with heart failure and chronic kidney disease.
At MannKind our employees are our greatest asset. We foster a close-knit collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds perspectives and working styles as we work together to improve health outcomes and change lives.
Job family summary:
Executes quality and manufacturing procedures in order to meet production demands and regulatory requirements. Responsibilities include on-time manufacture of intermediate semi-finished and finished pharmaceutical products that meet quality standards. Assists with establishing equipment operating specifications standard operating procedures and improving manufacturing techniques. Assists with equipment maintenance calibration and resolving technical issues.
Executes quality and manufacturing procedures in order to meet production demands and regulatory requirements. Responsibilities include on-time manufacture of intermediate semi-finished and finished pharmaceutical products that meet quality standards. Assists with establishing equipment operating specifications standard operating procedures and improving manufacturing techniques. Assists with equipment maintenance calibration and resolving technical issues.
Schedule:Every Other Wednesday but every Thursday Friday and Saturday 6:00 am to 6:30 pm. with a 5% Shift Differential
Essential duties and key job responsibilities and essential functions.
Essential duties and key job responsibilities and essential functions.
- Works on assignments that are semi-routine in nature where some judgment is required in resolving problems and making routine recommendations. Exercises some judgment within defined practices and policies in evaluating criteria for obtaining results.
- May provide guidance on assignments to other lower-level personnel.
- Execute manufacturing operations as required by Manufacturing Records according to Current Good Manufacturing Practices and Standard Operating Procedures in a clean room environment
- Performs manufacturing area and equipment setup cleanup and teardown and sanitization with supervision
- Operates manufacturing production equipment under supervision as required by Manufacturing Records and Standard Operating Procedures
- Performs in-process inspection and testing under supervision as required by Manufacturing Records and Standard Operating Procedures
- Accurately and completely documents manufacturing activities in appropriate Manufacturing Records Controlled Forms Product Container Labels and Logbooks
- Verifies and documents manufacturing steps performed by other Manufacturing Associates as correct in Manufacturing Records and / or Logbooks
- Responsible for observing all Company Health Safety and Environmental guidelines
- Fully qualified and able to operate approximately 50% of manufacturing equipment.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Section III: Minimum qualifications to perform the job; specific skills education knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
- High School/GED with minimum of 2 - 4 years related experience or the equivalent combination of experience and training.
- Must be willing and able to receive medical clearance to wear a respirator ( Air Purifying Respirator) for entire working shift.
- Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e. Tyvek jumpsuit).
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA ISO 13485 European requirements etc.)
Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
