Specialist Manufacturing

Weil Group • Juncos, PR

1d

About The Position

We are seeking a visionary Specialist Manufacturing professional to drive production excellence at the intersection of precision engineering and automation. In this role, you will optimize advanced manufacturing processes, implement cutting-edge Industry 4.0 technologies, and scale production lines to deliver next-generation products that shape our industry.

Requirements

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in performance of GMP production operations.
• Regulatory knowledge and interactions.
• Participate and help lead cross-functional teams.
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Organizational, technical writing and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

Nice To Haves

• Experience in Manufacturing area working with procedures.
• CAPA/ CAPA EV, Change Control, develop new procedures, enhance currents process, Implement new process, modify the current SOP’s, Provide training to operators.

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.
• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist with generation of process validation protocols and reports.
• Assist with the execution of the process validation.
• Support collection and analysis of process validation data.
• May participate in regulatory inspections.
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Assist manufacturing change owner on CCRB packages impacting the process.
• Participate on the assessment or implementation of special projects or initiatives.
• Other functions may be assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level