- 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
Excellent interpersonal skills
Requirements
ars of Manufacturing Operations experience
Alternatively, Associates + 8 years of Manufacturing Operations experience
Alternatively, High school/GED + 10 years of Manufacturing Operations experience.
Preferred:
Educational background in Life Sciences, Biology, Chemistry, and/or Engineering.
Skills Required
- Experience with bioprocessing unit operations
- Knowledge of Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why's, Kepner Tregoe)
- Familiarity with Lean Manufacturing practices
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
- Proficiency in Good Documentation Practices (GDP) in a regulated environment
- Experience with systems/tools: Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms
- Strong technical writing and presentation abilities
- Excellent written and verbal communication skills in English and Spanish
- Teamwork oriented with excellent interpersonal skills
- Ability to work under minimal supervision, under high workload/pressure, and extended hours
- Educational/experience requirement: Doctorate OR Master's + 2 years manufacturing operations experience; or Bachelor's + 4 years; or Associate's + 8 years; or High School/GED + 10 years
- Preferred educational background in Life Sciences, Biology, Chemistry, and/or Engineering
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
