The Role
Perform and support bioprocessing unit operations with root-cause analysis and lean manufacturing methods. Maintain Good Documentation Practices in a regulated environment, use Trackwise/VEEVA/MES and analytics tools, prepare technical writing/presentations, collaborate with manufacturing/process development/quality teams, work under minimal supervision and high workload, and be available for extended hours and overtime as needed.
Summary Generated by Built In
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/Tools: Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms
Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish
Teamwork Oriented
Able to work under minimal supervision and/or high workload and pressure
Able to work extended hours
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: M-F | 8am to 5pm | OT may be requested based on business needs.
Skills Required
- Experience with bio-processing unit operations
- Knowledge of Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Whys, Kepner Tregoe)
- Familiarity with Lean Manufacturing practices
- Ability to communicate and collaborate with technical and management staff in manufacturing, process development, and quality
- Proficiency in Good Documentation Practices (GDP) in a regulated environment
- Familiarity with systems/tools: Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms
- Strong technical writing and presentation skills; excellent written/verbal communication in English and Spanish
- Teamwork oriented, able to work under minimal supervision and/or high workload and pressure
- Able to work extended hours and overtime as needed
- Education/experience: Doctorate OR Master's +2 years manufacturing operations OR Bachelors +4 years OR Associates +8 years OR High school/GED +10 years
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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.
