Specialist - Manufacturing Inspection and Vials Packaging

Biopharma-Consulting-Jad-Group; Juncos (PR); Presencial; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Bioprocessing operations

GMP production operations

Regulatory knowledge

Cross-functional leadership

Communication & collaboration

Technical writing

Project management

Control charting

Formação académica

Doctorate

Master’s + 2 years experience

Bachelor’s + 4 years experience

Associate’s + 8 years experience

High School/GED + 10 years experience

Descrição da oferta de emprego

With minimal supervision, supports the execution of manufacturing and quality systems such as non‑conformances, process validation, procedures, training, and new product introductions. Applies process, operational, and scientific expertise, basic compliance knowledge, and analytical/troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities for more complex process systems.

Functions

• Initiate, revise, and approve manufacturing procedures; ensure all procedures reflect current operations. Serve as document owner.
• Assess process performance through floor observation and review of performance data; evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generating training materials and may support training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits.
• Collect process‑monitoring data and support deviation assessments.
• Support timely execution of quarterly process monitoring reports.
• Ensure all non‑conformances are triaged within established goals.
• Author investigation reports.
• Execute corrective actions.
• Manage NC/CAPA closure within established timelines.
• Monitor and communicate incident trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist in generating process validation protocols and reports.
• Support execution of process validation activities.
• Support collection and analysis of process validation data.
• May participate in regulatory inspections, New Product Introductions (NPI), and process or equipment modifications.
• Participate in NPI assessments for documentation, materials, training, and equipment modification requirements.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Assist manufacturing change owners with CCRB packages impacting the process.
• Participate in the assessment or implementation of special projects or initiatives.
• Other functions may be assigned.

Skills

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

• Doctorate OR

• Master’s + 2 years of Manufacturing Operations experience OR
• Bachelor’s + 4 years of Manufacturing Operations experience OR
• Associate’s + 8 years of Manufacturing Operations experience OR
• High School/GED + 10 years of Manufacturing Operations experience.

Preferred Qualifications

• Manufacturing Operations experience (not quality).
• Document management experience: creation, review, and approval of documents.
• Ability to work directly with manufacturing operators.

• 6-month contract with possible extension

• Shift / Schedule-Candidates must have availability to cover different shifts.