The Role
Support and own manufacturing process change controls, lead deviation and root cause investigations, design and execute process/challenge tests, support CAPA/BOM/MBR activities, enable campaign readiness, create training/materials, and drive process improvement and documentation in a regulated bioprocessing manufacturing environment.
Summary Generated by Built In
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 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.
Requirements
Doctorate OR Master’s + 2 years of Manufacturing Operations experience
OR Bachelors + 4 years of Manufacturing Operations experience
OR Associates + 8 years of Manufacturing Operations experience
OR High school/GED + 10 years of Manufacturing Operations experience
Shift: 8 hour shift, Mon-Fri 8am-5pm (flexibility for on-call support at any time)
Preferred Qualifications:
• Educational background in Life Sciences and/or Engineering.
• In-depth experience of bio-processing unit operations (Cell Culture, Drug Substance Purification)
• 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
Skills Required
- Doctorate OR Master's + 2 years OR Bachelors + 4 years OR Associates + 8 years OR High school/GED + 10 years of Manufacturing Operations experience
- Experience in Manufacturing Operations
- Ability to work 8 hour shift, Mon-Fri 8am-5pm, with flexibility for on-call support
- Educational background in Life Sciences and/or Engineering
- In-depth experience of bio-processing unit operations (Cell Culture, Drug Substance Purification)
- Knowledge in Root Cause Analysis methodologies (Fishbone, 5 Why's, Kepner Tregoe, etc.)
- Familiarity with Lean Manufacturing practices
- Proficiency in Good Documentation Practices (GDP) in a regulated environment
- Knowledge of systems: Trackwise, Spotfire, CDOCS, and other process monitoring platforms
- Strong technical writing and presentation skills; excellent written/verbal communication in English and Spanish
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The Company
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
