Bio-Processing Manufacturing Specialist

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico seeks a Manufacturing Operations professional to lead bio-processing unit operations, apply root-cause analysis, and drive lean improvements. You will document processes under GDP in a regulated environment, collaborate with technical and management staff, and leverage TrackWise, VEEVA, MES, Power BI and Spotfire.

The role requires excellent technical writing, English and Spanish communication, and the ability to work

Qualifications

• 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

Job description

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico seeks a Manufacturing Operations professional to lead bio-processing unit operations, apply root-cause analysis, and drive lean improvements. You will document processes under GDP in a regulated environment, collaborate with technical and management staff, and leverage TrackWise, VEEVA, MES, Power BI and Spotfire.

The role requires excellent technical writing, English and Spanish communication, and the ability to work