Specialist - Manufacturing

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Biopharma-Consulting-Jad-Group in Juncos, PR, seeks a manufacturing operations specialist to support GMP production, process validation, deviations, CAPA, and NPI activities under minimal supervision.

You will initiate and approve procedures, analyze process data, assist with training, and help manage NC/CAPA closures, TR reporting, and regulatory interactions.

This 6-month contract offers hands-on bioprocess experience, collaboration with QA, manufacturing, and process development teams.

Qualifications

• Doctorate OR Master’s with manufacturing ops experience.
• Bachelor’s with 4+ years manufacturing ops OR Associate’s with 8+ years.
• High School/GED with 10+ years manufacturing ops.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure all procedures reflect current operations.
• 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

Bioprocessing ops

GMP operations

Cross-functional teams

Regulatory know-how

Technical writing

Root cause analysis

Education

Doctorate

Master’s + 2 yrs exp

Bachelor’s + 4 yrs exp

Associate’s + 8 yrs exp

High School/GED + 10 yrs exp

Tools

TrackWise

Job description

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

• Bachelor’s degree in engineering is a plus.
• Deviations management experience.
• Deviation assessments.
• Experience with TrackWise.
• Biotech and manufacturing experience.

• 6-month contract with possible extension
• Shift / Schedule: 8‑hour shift | Administrative
• Availability to work overtime may be required based on business demand.