Pharmaceutical manufacturer on the south side of Charlotte, NC. Strong growth potential and very active team/family environment.
We are looking for a Process Engineer candidate that will possess a thorough understanding and wide application of technical principles, theories, and concepts in the field. Responsible for the management and execution of commercial product support projects in the areas of product technical transfer, product/process improvement and optimization, scale-up, troubleshooting and investigation. The Process Engineer will serve as a technical resource in process development, process/equipment troubleshooting, process optimization/scale-up, and technology transfer in Sterile Injectables and Nebulizer areas.
Performs process/equipment troubleshooting activities for daily support of manufacturing.
Write scientific documents to support justification for process scale-up, technology transfer, and/or equipment changes.
Support process validation batches by writing and executing process validation protocols and support Production during execution.
Develops experimental plans for process development.
Evaluates and develops new technologies.
Executes experimental, clinical, stability, and validation batches.
Provides technical review of contracted and internal formulation and development work for transfer candidate products.
Performs root cause identification of product/process related investigations
Uses judgment, creativity, and sound technical knowledge to obtain and recommend solutions/CAPAs.
Authors development and investigation reports, protocols, specifications, procedures.
Writes experimental, pivotal, validation/commercial batch records.
Reviews GMP documents (MBRs, SOPs, protocols) and generates change controls.
Assist in writing proof of principle protocols, assist in writing and developing design specifications and IQ/OQ/PQ protocols.
Understand the operation and be able to monitor manufacturing equipment utilizing HMIs for parts washerm autoclave, vial washers, dehydrogenation tunnels, fillers, etc.
Collaborate with relevant departments in writing and executing master formula cards in support of batch improvement.
Perform trending and monitoring of critical quality attributes, critical process parameters to maintain product quality.
Evaluate new manufacturing equipment, materials and processes; assist in review and writing of protocols, assist in reviewing design specifications and qualification protocols. Assist in review and writing of SOPs.
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, 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.
Provides input in the selection of new equipment and technologies to support the plants processes.
Support test runs, validation runs, engineering runs, and any other requirements as needed during the manufacturing work hours as applicable (be available “on call” for after hours).
Works under limited supervision of management and/or team leads.
- Bachelor’s degree or advanced degree in Science, Engineering, or Pharmaceuticals.
- Minimum of 5 -7 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.