QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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We are seeking a Sr. Engineer responsible for:

• Own change controls for manufacturing process changes
• Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
• Support Risk Assessments exercises and Microbial assessment evaluations.
• Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
• Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
• Provide commercial support when needed and assist on the floor troubleshooting.
• Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.
• Assist and provide guidance during MBR (Master Batch Record) creation/revisions.
• Perform assessment to support process, automation, or equipment modification or implementation of special projects
• Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Complete assessments for CAPA applicability requests from other plants/sites
• Complete assessment for new or changes in BOM's (Bill of Materials)
• Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.

• BS in Engineering.

• In-depth experience of bio-processing unit operations

• Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe)

• Familiar with Lean Manufacturing Practices

• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.

• Proficiency in GDP (Good Documentation Practices) on a regulated environment

• Knowledge in systems: Trackwise, Spotfire, CDOCS, and process monitoring platforms

• Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish

​8 hour shift, Mon-Fri 8am-5pm (flexibility for on-call support at any time

All your information will be kept confidential according to EEO guidelines.