The Manufacturing Operations Support Engineer will provide on floor technical support to manufacturing operations, work with investigation teams in solving complex manufacturing issues, identify opportunities to improve manufacturing processes and cGMP documentation and analyze manufacturing process control data.
Technical Support
- Provides daily on-the-floor technical support to manufacturing operations.
- Write and review batch records.
- Identify areas of process risk identify, assess, and implement risk mitigation strategies.
- Tracks, trends, and communicates process performance.
Validation
- Leads process validation and verification efforts.
- Possesses an understanding of the principles related to the validated states of the process and process equipment.
Training/Compliance
- Promote “Right First Time” philosophy for all manufacturing activities.
- Provide technical training to manufacturing personnel.
- Participate in change controls and product deviation investigations.
Deviation Management
- Ensures manufacturing staff identify and document events that deviate from normal operation.
- Provide technical support to deviation investigations.
- Completes investigations, reports, and proposes CAPA for minor deviations.
Continuous Improvement
- Supports plant floor continuous improvement initiatives (Process and Value Stream Mapping).
- Supports the creation manufacturing SOP’s that ensures manufacturing operations stay aligned with the validated process.
Basic Qualifications:
- BS in Chemical or Biochemical Engineering (or similar) with 0-2 years manufacturing floor experience.
- Demonstrated understanding of biologics manufacturing, scale-up and validation principles.
- Excellent problem solver and ability to generate innovative solutions to broad range of issues.
- Good understanding of experimental design and statistical process evaluation.
- Ability to explain complex technical issues to other functions in clear and understandable terms.
Preferred Qualifications:
- Familiarity with one or more upstream or downstream process unit operation design typically used in biotech manufacturing (cell expansion, fermentation & cell culture, harvest / clarification, purification).
- Previous experience with process or equipment validation
- Ability to evaluate new technologies/techniques.
All your information will be kept confidential according to EEO guidelines.
