Specialist - Manufacturing Assembly and Packaging

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 90,000 - 120,000; Part time

Job summary

BioPharma Consulting JAD Group seeks a Manufacturing Operations professional to support execution of manufacturing and quality systems, including non‑conformances, process validation, procedures, training, and new product introductions.

The role may serve as primary process owner for process support systems and assist with ownership of more complex systems, collaborating with manufacturing, quality, and process development teams. 6‑month contract with possible extension, administrative shift.

Qualifications

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

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance and implement improvements.
• Provide troubleshooting support.
• Assist in generating training materials and training.
• Support process monitoring parameters and control limits.
• Collect process monitoring data and support deviation assessments.
• Ensure timely execution of quarterly process monitoring reports.
• Triage non-conformances within goals and author investigation reports.
• Execute corrective actions and CAPA closure.
• Monitor incident trends and review RCA investigations.
• Assist in process validation protocols and reports; support validation activities.
• Participate in regulatory inspections and NPI assessments.
• Assess and support modification projects and CCRB packages.
• Support special projects and other duties as assigned.

Education

Doctorate

Master’s + 2 years of Manufacturing Operations experience

Bachelor’s + 4 years of Manufacturing Operations experience

Associate’s + 8 years of Manufacturing Operations experience

High School/GED + 10 years of Manufacturing Operations 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

• Knowledge of document handling in Veeva Vault (CDOCs) or similar platforms.
• Technical writing expertise.
• Experience as change control owner.
• Project handling experience.
• Experience using Smartsheet or similar platforms.

• 6-month contract with possible extension
• Administrative Shift