Bioprocess Assembly & Packaging Specialist

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

6-month contract

Administrative Shift

Job summary

Biopharma-Consulting-Jad-Group seeks a Manufacturing Operations Support Specialist to assist in executing manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions, under minimal supervision.

You will apply process, scientific, and regulatory knowledge to support operations, act as document owner for procedures, generate training materials, and help drive continuous improvement in collaboration with QA, manufacturing,

Qualifications

• Bachelor’s degree in life sciences with manufacturing ops experience.
• Experience with GMP and quality systems in manufacturing.
• Strong analytical and troubleshooting abilities.
• Regulatory knowledge and cross-functional collaboration.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance and implement improvements.
• Provide troubleshooting support.
• Assist in training materials for scientific/technical topics.
• Support process monitoring parameters and control limits.
• Collect data and support deviation assessments.
• Ensure timely NC/CAPA closure within timelines.
• Coordinate investigations and corrective actions.
• Assist in regulatory inspections and NPI assessments.
• Participate in special projects and process/equipment modifications.
• Other functions may be assigned.

Skills

Bioprocessing knowledge

GMP operations

Regulatory knowledge

Cross-functional teamwork

Communication

Technical writing

Project management basics

Control charts

Education

Doctorate

Master’s + 2 years manufacturing operations experience

Bachelor’s + 4 years manufacturing operations experience

Associate’s + 8 years manufacturing operations experience

High School/GED + 10 years manufacturing operations experience

Tools

Veeva Vault (CDOCs)

Smartsheet

Job description

Biopharma-Consulting-Jad-Group seeks a Manufacturing Operations Support Specialist to assist in executing manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions, under minimal supervision.

You will apply process, scientific, and regulatory knowledge to support operations, act as document owner for procedures, generate training materials, and help drive continuous improvement in collaboration with QA, manufacturing,