Biotech GMP Manufacturing Specialist - NPI & Process Owner

ProQualityNetwork; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

ProQualityNetwork is seeking a Specialist Manufacturing to support execution and maintenance of manufacturing and quality systems, including NPI and process validation. This role requires applying process expertise, analytical thinking, and troubleshooting to ensure efficient operations on the production floor.

The candidate will serve as a primary production process owner for assigned systems while collaborating with Process Development and Quality teams to drive continuous improvements and

Qualifications

• Detailed technical understanding of bioprocessing unit operations.
• Proficiency in GMP manufacturing and production operations.
• Knowledge of regulatory requirements and experience supporting regulatory interactions.
• Ability to participate in and help lead cross-functional teams.
• Strong communication and collaboration skills, with the ability to work effectively with technical and management personnel across Manufacturing, Process Development, and Quality.
• Strong organizational, technical writing, and presentation skills.
• Basic project management knowledge and skills.
• Basic knowledge of statistical process control (SPC) and control charting.

Responsibilities

• Initiate, revise, and approve manufacturing procedures, ensuring all documentation accurately reflects current manufacturing operations.
• Assess process performance through direct observation of floor operations and review of performance data; implement solutions for improvements.
• Provide technical troubleshooting support to resolve manufacturing process issues.
• Assist in developing training materials and provide training on manufacturing processes.

Skills

Bioprocessing knowledge

GMP manufacturing

Regulatory experience

Cross-functional teamwork

Technical writing

Education

Master's degree + 2 years

Bachelor's degree + 4 years

Associate degree + 8 years

High school diploma or GED + 10 years

Job description

ProQualityNetwork is seeking a Specialist Manufacturing to support execution and maintenance of manufacturing and quality systems, including NPI and process validation. This role requires applying process expertise, analytical thinking, and troubleshooting to ensure efficient operations on the production floor.

The candidate will serve as a primary production process owner for assigned systems while collaborating with Process Development and Quality teams to drive continuous improvements and