What are the responsibilities and job description for the Senior Process Engineer position at C-Care LLC?
SUMMARY OF POSITION:
The SeniorProcess Engineer is responsible for the technical transfer of customer and internal formulations from a lab to production scale as well as the optimization of the batching process to establish effective, efficient, and quality production standards.
ESSENTIAL FUNCTIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job. Other duties may be assigned.
- Accept, Review, and Translate confidential customer and internal formula documentation into C-Care’s working processes and document control system.
- Conducts research to develop new and improved processes for manufacturing
- Conducts tests and monitors the process performance throughout production
- Work with customers to prepare a working batch process for customer lab, pilot and/or zero batch production.
- Collaborate with customers on-site and offsite to provide necessary data and project updates. Maintain updated knowledge of the customers' unique change control and product validation processes.
- Troubleshoot processes during pilot and zero-batch production.
- Provide ongoing technical support for the product throughout the entire production life cycle.
- Maintain customer formula files.
- Maintain database of production processes and batch card sheets.
- Create, maintain and improve batching templates and processes.
- Prepare laboratory batches for customer when needed.
- Review new formula or updated formula production models to ensure accuracy.
- Work closely with the Plant Manager and Scheduler to establish customer zero and pilot batch schedule.
- Provide input to technical assumption sheet for new and existing business (re)quoting efforts.
- Manage the tech transfer timeline for new projects.
- Investigate OOS batches through site deviation process.
- Maintain and update site SOPs and WIs used in the compounding department.
- Work with all site engineers, technical management, and compounders on continuous improvement ideas for the processing area.
- Use statistical tools to monitor key product parameters.
- Coordinate with supply chain representatives to contact new and/or existing suppliers for lab samples and/or technical information.
- Conduct minor stability of laboratory batches with support of site stability specialist when required by the customer.
Qualifications
- Bachelor’s degree in Chemical Engineering, Chemistry or related field.
- 3-5 years of chemical engineering-related and/or QA-related experience in a manufacturing facility with strong chemistry knowledge.
- Prior experience with data analysis and trending is required.
- Prior experience with process improvement and leading projects.
- Strong communication, organizational and planning skills are required for customer interaction and project presentations.
- Sampling of batches may require lifting tank, tote, or drum lids and/or shifting around 55 lb. bags of raw material; lifting of 5 gallon reagent chemical drums; walking throughout facility (approx. 100,000 sq. ft); and climbing stairs to the processing area and to various storage tanks.
- Use of partial/full respirator and training is required.
- Six Sigma Certification/Experience Preferred
- Lean Manufacturing Certification/Experience Preferred
- Prior experience in a GMP and ISO 22716 environment is a plus.
