Bioprocess Inspection Specialist - Vials & Packaging

Biopharma-Consulting-Jad-Group

Juncos (PR)

On-site

USD 90,000 - 130,000

Full time

3 days ago
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Job summary

Biopharma-Consulting-Jad-Group is seeking a Manufacturing Operations professional to support bioprocessing and quality systems in a primarily on-site role at the Puerto Rico site. The role involves procedure ownership, data-driven improvement, and hands-on troubleshooting across manufacturing processes.

The candidate will help manage NC/CAPA, generate training materials, and participate in process validation activities and potential regulatory inspections.

Qualifications

  • PhD or equivalent with manufacturing operations experience.
  • Masters or higher with at least 2 years of ops exposure; strong GMP knowledge.
  • Bachelor’s with 4+ years of manufacturing ops experience; proven track record.

Responsibilities

  • Initiate, revise, and approve manufacturing procedures; serve as document owner.
  • Assess process performance and implement improvements based on data.
  • Provide troubleshooting support for manufacturing issues.
  • Assist in generating training materials for process operations.
  • Support NC/CAPA closure and deviation investigations within timelines.
  • Participate in regulatory inspections and NPI assessments.

Skills

Bioprocessing operations
GMP production operations
Regulatory knowledge
Cross-functional leadership
Communication & collaboration
Technical writing
Project management
Control charting

Education

Doctorate
Master’s + 2 years experience
Bachelor’s + 4 years experience
Associate’s + 8 years experience
High School/GED + 10 years experience

Job description

Biopharma-Consulting-Jad-Group is seeking a Manufacturing Operations professional to support bioprocessing and quality systems in a primarily on-site role at the Puerto Rico site. The role involves procedure ownership, data-driven improvement, and hands-on troubleshooting across manufacturing processes.

The candidate will help manage NC/CAPA, generate training materials, and participate in process validation activities and potential regulatory inspections.

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