Production Supervisor (Nebulizer)
|Monroe, North Carolina - United States
$65,000.00 - $75,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are actively seeking a Supervisor for the Nebulizer team. The candidate will have thorough understanding of the Nebulizer drug manufacturing process (Blow Fill Seal (BFS) or Form Fill Seal) to provide process supervision for the related qualification activities for a greenfield new facility. The candidate will serve as a technical resource in process development, process/equipment troubleshooting, process optimization/scale-up, and technology transfer. The candidate will supervise the day to day activities of production associates
Supervise production activities including Formulation, Filling, Inspection, Packaging, Labeling and Sanitization. Schedule production activities and coordinate activities of support groups and Communicate production priorities and progress to team on a continuing basis. The candidate will maintain records and a clean environment to comply with regulatory requirements in compliant with Good Manufacturing Practices and Standard Operating Procedures.
Responsibilities include but are not limited to:
- Domestic and international travel up to 5% is required.
- Collaborate with relevant departments in writing and executing master formulas in support of batch improvement.
- Evaluate new manufacturing equipment, materials and processes; assist in writing proof of principle protocols, assist in writing and developing design specifications and IQ/OQ/PQ protocols.
- Assists during the development of new products to provide a commercial operations perspective to process design and development of new products. Provide input regarding application of technologies that will optimize capital investment to provide robust, productive, and practical processes at commercial scale.
- Develop, execute and write-up process and cleaning validation documentation.
- Develop, evaluate and implement improvements to existing processes to optimize production output and reduce production cycle-time.
- Use critical thinking and problem solving skills to independently identify and solve technical problems related to the manufacture and packaging of products.
- Oversee selection of new equipment and technologies to support the plants processes.
- Review/Update current SOPs/batch records as well as write new SOPs/batch records, and protocols
- Assist associates with in-process testing to assure batches meet specifications
- Ensure weights, measures and raw materials are managed appropriately to assure batches manufactured contain proper ingredients and quantities
- Manage the performance of Production Associates and Leads
- Assist with the operation and maintenance of production equipment
- Perform line clearances, cleaning/sanitization, CIP and SIP process equipment, filter testing, operation of Blow Fill Seal process equipment
- Lead troubleshooting and process improvement activities including corresponding documentation activities
- Initiate appropriate action when process deviations occur
- Execute validation protocols for processes and equipment
- Reviews GMP documents (MBRs, SOPs, RM specifications, protocols) and generates change controls.
- Works under limited supervision of management and/or team leads.
- Assist in writing proof of principle protocols, assist in writing and developing design specifications and IQ/OQ/PQ protocols.
- Provide a summary statement of the Completion of Installation & Qualification status.
- Provide a report attachment listing the deficiencies and suggested corrective actions to complete the qualification of the system.
- This position will be responsible for the supervision of the BFS team.
- Bachelor’s degree or advanced degree in Science, Engineering, or Pharmaceuticals
Experience, Knowledge & Skills:
- Minimum of 5 (five) years in formulation/process development, manufacturing support, scale-up, validation and technology transfer experience
- Possesses project management skills; strong verbal and written communication skills.
- Possesses applied knowledge of root cause analysis and troubleshooting techniques. Able to apply statistical analyses and experimental design techniques. Technical competence and writing skills.
- Strong customer/quality focus. Knowledge of pharmaceutical GMPs and regulatory (FDA, DEA, OSHA) requirements. Adherence to all health, safety, and environmental requirements. Work in safe and efficient manner.
- Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines
- Very strong knowledgeable in FDA regulations, industry Best Practices and FDA expectations.
University - Bachelor's Degree/3-4 Year Degree