Senior Process Engineer
- Posted: over a month ago
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.
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.
- 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.
AddressLinthicum Heights, MD
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