Senior Process Engineer

•

•

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.