The Role
The role involves owning manufacturing change controls, supporting investigations, leading campaign readiness, generating training materials, and improving manufacturing processes.
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
Alternatively, Bachelors + 4 y
ears of Manufacturing Operations experience
Alternatively, Associates + 8 years of Manufacturing Operations experience
Alternatively, High school/GED + 10 years of Manufacturing Operations experience.
Preferred Qualifications:
• Educational background in Life Sciences and/or 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
Skills Required
- Doctorate or Master's degree and 2 years of experience in Manufacturing Operations
- Bachelor's degree and 4 years of experience in Manufacturing Operations
- Associates degree and 8 years of experience in Manufacturing Operations
- High school diploma/GED and 10 years of experience in Manufacturing Operations
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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.
