Bioprocess Manufacturing Specialist – Assembly & Packaging

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 90,000 - 120,000; Part time

Job summary

BioPharma Consulting JAD Group seeks a Manufacturing Operations professional to support execution of manufacturing and quality systems, including non‑conformances, process validation, procedures, training, and new product introductions.

The role may serve as primary process owner for process support systems and assist with ownership of more complex systems, collaborating with manufacturing, quality, and process development teams. 6‑month contract with possible extension, administrative shift.

Qualifications

• Advanced knowledge of bioprocessing unit operations.
• GMP production operations experience.
• Regulatory knowledge and interactions.
• Ability to lead cross‑functional teams.
• Strong communication and collaboration with manufacturing, process development, and quality teams.
• Organizational, technical writing, and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance and implement improvements.
• Provide troubleshooting support.
• Assist in generating training materials and training.
• Support process monitoring parameters and control limits.
• Collect process monitoring data and support deviation assessments.
• Ensure timely execution of quarterly process monitoring reports.
• Triage non-conformances within goals and author investigation reports.
• Execute corrective actions and CAPA closure.
• Monitor incident trends and review RCA investigations.
• Assist in process validation protocols and reports; support validation activities.
• Participate in regulatory inspections and NPI assessments.
• Assess and support modification projects and CCRB packages.
• Support special projects and other duties as assigned.

Education

Doctorate

Master’s + 2 years of Manufacturing Operations experience

Bachelor’s + 4 years of Manufacturing Operations experience

Associate’s + 8 years of Manufacturing Operations experience

High School/GED + 10 years of Manufacturing Operations experience

Job description

BioPharma Consulting JAD Group seeks a Manufacturing Operations professional to support execution of manufacturing and quality systems, including non‑conformances, process validation, procedures, training, and new product introductions.

The role may serve as primary process owner for process support systems and assist with ownership of more complex systems, collaborating with manufacturing, quality, and process development teams. 6‑month contract with possible extension, administrative shift.