Sr Engineer 35392
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Job Summary
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 BOMs (Bill of Materials)
Serves as a peer-recognized specialist in at least one area with overall responsibility for determining methodologies in that area.
Requirements
Doctorate OR Masters 2 years of Engineering experience
OR bachelors in engineering 4 years of Engineering experience.
Preferred Qualifications:
Educational background in Life Sciences and Engineering.
In-depth experience of bio-processing unit operations
Knowledge in Root Cause Analysis methodologies (Fishbone Six Boxes Fishbone 5 Whys 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
Required Skills:
Specific responsibilities include but are not limited to: 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 BOMs (Bill of Materials) Serves as a peer-recognized specialist in at least one area with overall responsibility for determining methodologies in that area.
Required Education:
Doctorate OR Masters 2 years of Engineering experience OR bachelors in engineering 4 years of Engineering experience. Preferred Qualifications: Educational background in Life Sciences and -depth experience of bio-processing unit operations Knowledge in Root Cause Analysis methodologies (Fishbone Six Boxes Fishbone 5 Whys Kepner Tregoe) Familiar with Lean Manufacturing Practices Ability to communicate and collaborate with technical and manag
