Bio-Process Manufacturing Specialist - Process Owner

PRPDG; Juncos (PR); On-site; USD 80,000 - 105,000; Full time

Job summary

PRPDG is seeking a highly capable professional to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. You will apply scientific and analytical skills to assist with process ownership and operations, potentially serving as the primary production process owner for select systems.

The role requires extensive knowledge of bio-processing unit operations, strong root cause analysis capabilities, proficiency in

Qualifications

• 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.
• 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

Skills

Technical writing

Verbal communication

Written communication

English/Spanish fluency

Teamwork

Analytical troubleshooting

Problem solving under pressure

Education

Doctorate

Master's degree + 2 years manufacturing experience

Bachelor's degree + 4 years manufacturing experience

Associates degree + 8 years manufacturing experience

High school/GED + 10 years manufacturing experience

Tools

TrackWise

VEEVA

MES

Smart Sheet

ChatGPT

Copilot

Power BI

Spotfire

CDOCS

Process monitoring platforms

Job description

PRPDG is seeking a highly capable professional to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. You will apply scientific and analytical skills to assist with process ownership and operations, potentially serving as the primary production process owner for select systems.

The role requires extensive knowledge of bio-processing unit operations, strong root cause analysis capabilities, proficiency in