Jonathan Willman Email & Phone Number

Bend, Oregon (Remote)

San Diego, California, United States

Bend, Oregon Area

• Technical writer for Master Batch Records (MBRs) related to spray drying, granulation, pan coating, tableting, packaging, and capsule filling.• Reviews Executed Batch Records (EBRs) for technical accuracy and adherence against procedures• Serves as manufacturing representative for Practical Process Improvements (PPI) (i.e., continuous improvement projects). Streamlined existing processes to eliminate waste, increase efficiency, or decrease cost. Served as facilitator to communicate needs of manufacturing personnel to the PPI site lead.• Collaborates with clients and formulation group to author accurate MBRs. Provides training for authored MBRs.• Works with Project Management and Quality to ensure timely release of batches• Designs training modules for new equipment. Revises existing training to reflect significant changes in processes.• Authors SOPs for new equipment. Reviews SOP revisions.• Reviews validation documents (User Requirement Specifications)

Bend, Oregon, United States

• Supervised GMP production activities including routine cleaning, execution of GMP manufacturing and equipment preparation activities. • Directly supervised Operators (up to 16 personnel). • Scheduled manufacturing campaigns and ran day-to-day operations. • Monitored personnel completion of training to ensure adequate staffing for manufacturing campaigns. • Performed goal-setting and personnel reviews for direct reports. • Wrote, reviewed, and approved deviations, CAPAs, change controls, calibration failures, validation periodic reviews, SOPs and other Quality documents.• Scheduled and assisted in equipment and process qualification/validations.• Reviewed Master Batch Records (MBRs) and Executed Batch Records (EBRs)• Responsible for timely review of logbooks.• Subject Matter Expert for small-scale spray drying, portable process tanks, and tray drying equipment. Built training program requirements related to these processes.

Bend, Oregon Area

• Provided guidance to operations personnel on training and GMP execution activities• Reviewed and approved logbooks associated with production areas and activities• Released cleaning events of equipment for use in manufacturing• Authored Standard Operating Procedures (SOPs)• Authored, reviewed, and approved pre-execution Master Batch Records (MBRs). Performed technical review of executed batch records• Prepared, reviewed, and approved validation documents for equipment. Assisted in qualification activities.• Participated in equipment commissioning activities, including risks assessments.• Performed tasks as a Hazardous Waste worker.• Responsible for own work and provided direction to Operators for standard procedures, equipment operations, and MBR execution.• Made decisions during manufacturing runs with timely notice to management and QA.• Participated in interdepartmental continuous improvement projects.

Bend, Oregon, United States

• Operated various equipment in GMP and Development runs, including, but not limited to: small-scale spray dryer, tray dryer, Dynomil, MP-2, roller compactor, blender, Comil, tablet press equipment, pan coater, laser drill, packaging and labeling, etc.• Performed cleaning and post-production maintenance of various equipment and facility.• Revised Standard Operating Procedures.• Authored deviations, CAPAs, and change controls.

Bend, Oregon Area

• Performed daily reports and deposits.• Managed part-time and full-time mechanics.• Performed daily work orders. Dispatched service calls.• Managed accounts payable and receivable.• Served as forklift operator and performed maintenance on forklifts.

Bend, Oregon Area

• Opened and closed facility. Managed day-to-day of entire facility.• Performed daily reports and deposits.• Managed and scheduled all employees.• Managed payroll, accounts payable and receivable.• Enforced and ensured that environment was safe for all team members.• Managed all inventory, ordering and selling of supplies.• Managed all sport programs, including adult and youth soccer.• Managed all advertising contracts. Marketing and promoting all new business.

Vancouver, Washington