Specialist - Manufacturing Inspection and Vials Packaging

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

BioPharma Consulting JAD Group is seeking a Manufacturing Operations Specialist to support bioprocess manufacturing and quality systems with minimal supervision. You will manage procedures, drive process improvements, and participate in investigations, CAPA, and process validation activities for new product introductions.

The role requires strong GMP knowledge, regulatory understanding, and the ability to work with cross-functional teams including operations, quality, and process development.

Qualifications

• Doctorate or equivalent manufacturing operations experience.
• Experience with manufacturing procedures, deviations, CAPA, and change control.
• Ability to work with cross-functional teams and document management.
• Knowledge of GMP and regulatory interactions.
• Strong communication, technical writing, and presentation skills.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance and plan improvement solutions.
• Provide troubleshooting support.
• Assist in generating training materials and support training.
• Support process monitoring parameters and control limits.
• Collect process-monitoring data and support deviation assessments.
• Ensure NC/CAPA closure within timelines.
• Author investigation reports and execute corrective actions.
• May participate in regulatory inspections and NPI assessments.
• Assess and implement process/equipment modification projects.
• Assist CCRB packages impacting the process.
• Other functions may be assigned.

Skills

Bioprocessing knowledge

GMP knowledge

Regulatory knowledge

Cross-functional leadership

Communication skills

Technical writing

Project management

Control charts

Education

Doctorate

Master’s degree + experience

Bachelor’s degree + experience

Associate’s degree + experience

High School/GED + experience

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

• 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.