Biotech Manufacturing Inspection & Vial Packaging Lead

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

BioPharma Consulting JAD Group is seeking a Manufacturing Operations Specialist to support bioprocess manufacturing and quality systems with minimal supervision. You will manage procedures, drive process improvements, and participate in investigations, CAPA, and process validation activities for new product introductions.

The role requires strong GMP knowledge, regulatory understanding, and the ability to work with cross-functional teams including operations, quality, and process development.

Qualifications

• Doctorate or equivalent manufacturing operations experience.
• Experience with manufacturing procedures, deviations, CAPA, and change control.
• Ability to work with cross-functional teams and document management.
• Knowledge of GMP and regulatory interactions.
• Strong communication, technical writing, and presentation skills.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance and plan improvement solutions.
• Provide troubleshooting support.
• Assist in generating training materials and support training.
• Support process monitoring parameters and control limits.
• Collect process-monitoring data and support deviation assessments.
• Ensure NC/CAPA closure within timelines.
• Author investigation reports and execute corrective actions.
• May participate in regulatory inspections and NPI assessments.
• Assess and implement process/equipment modification projects.
• Assist CCRB packages impacting the process.
• Other functions may be assigned.

Skills

Bioprocessing knowledge

GMP knowledge

Regulatory knowledge

Cross-functional leadership

Communication skills

Technical writing

Project management

Control charts

Education

Doctorate

Master’s degree + experience

Bachelor’s degree + experience

Associate’s degree + experience

High School/GED + experience

Job description

BioPharma Consulting JAD Group is seeking a Manufacturing Operations Specialist to support bioprocess manufacturing and quality systems with minimal supervision. You will manage procedures, drive process improvements, and participate in investigations, CAPA, and process validation activities for new product introductions.

The role requires strong GMP knowledge, regulatory understanding, and the ability to work with cross-functional teams including operations, quality, and process development.