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Senior Process Engineer

C-Care LLC
Linthicum Heights, MD
  • Posted: over a month ago
  • Full-Time
Job Description

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.

C-Care LLC

Address

Linthicum Heights, MD
21090 USA

Industry

Manufacturing

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