Timothy O. Wilcox

• •Provide commissioning, qualification, and operational readiness support during Start-up project phase of Filling area
• Participates in Water Runs, AFPT (Air-Flow Pattern Testing/Smoke Studies) Cycle Development, FAT, SAT and Scale-Ups
• •Demonstrates ability to act as SME in manufacturing processes, including Aseptic filling, Isolator/RABS technology and Terminal Sterilization
  •Developed performance evaluations of Filling Leads and operators
  •Key liaison between operations and support functions, ie Quality, engineering, automation etc
  •Ensure all operators are trained on PMX (electronic batch record), SAP, Cleaning Logs, etc.
  •Hiring operators to ensure shift is fully staffed for production
  •Assisted headquarters site in Indianapolis for three months to ensure operators and technicians following Aseptic techniques and procedures during production
  •Traveled to Italy for one month to further train on PFS (Pre-filled Syringes) machine and processes
  •Provides team building activities to ensure shift and moral are in good standings
  •Experience utilizing filling equipment, isolator technology, Aseptic Process Simulation (APS)
  •Delegating shift operations, approving time, vacations, ensuring attendance remains in good standing
  •Ensure all operator SOP trainings are completed and up to date
• Placing orders for new parts and materials for Isolator, Palletizer and GIT machine
• Assigned tasks to operators and monitored productivity, performance and task completion.
• Part of FFE (Furniture Fixture & Equipment) Team responsible for ordering plant furniture and fixtures for entire Filling area...ie, 316 Stainless Steel grade benches, cabinets, tables, carts, Isolator glove stand holder, etc

•Leads shift and shift huddles during supervisor's absence
•Setup, Operate and troubleshoot Bausch and Stroebel Vial Washer, Depyrogenation Tunnel and Isolator
•Executes manufacturing process steps per current SOP's
•Supports manufacturing activities, monitoring the process against the batch record BPR and control systems.
• Was in training to coordinate and lead process steps as required, to become process SME.
•Documents/records and review cGMP data and information for processing steps
or equipment activities, following standard SOP's.
•Review batch record, equipment and cleaning logbooks for accuracy and ensure any errors were corrected
•Participates in training activities, provides training to other associates and shares
knowledge with others.

•Start-up conditions, worked with contractors and maintenance assembling filling line
•Setup, changeover, operate, troubleshoot Groninger Isolator/filler,
Depyrogenation tunnel and Vial Washer.
•Trained for three months with ROTA vendor on operating and troubleshooting PFS (Pre-filled Syringe) machine
•Trained operators on running the PFS machine and Vial Washer, Tunnel and Isolator/Filler
•Assist Sterilization team with Autoclaving parts and Formulation with product filtration
•Performed Bi-annual, monthly, weekly and daily cleanings of area
• VHP, SIP, CIP and Cool Zone Sterilization cycles.
•Worked on eliminating issues by changing out Differential Pressure sensors for Depyrogenation tunnel to eliminate heating issues while running process
•Assists and cover for supervisor with shift activities and team management
• Assists/participated in CAPA's, batch record review, investigations, Scale Ups, Media fills,

•Ensure all team members are trained on equipment and procedures
• Trained and certified in Visual Inspection
•Responsible for repairing Tare and Gross servo robots for Filler when clutch had disengaged.
•Installed RTD's for 12 needles of Filler to regulate temperature of product as it
flowed through needles, which would eliminate downtime.
•Installed new systems, replacement parts and components to maintain proper
operation.
•Coordinated with Bausch and Stroebel vendors to prepare for training, large
system installations and complex repairs.
•Experience utilizing MES and Delta-V to monitor filling process, CIP, SIP, Depyrogentation Tunnel Cool Zone Sterilization and Isolator VHP
•Performed all EM procedures to ensure efficient testing and monitoring done at end of campaigns

• Utilized RT-Reports program to document, research and troubleshoot any issue during the process
•Performed PM's to ensure proper machine operation during production

• Cleaned or lubricated shafts, bearings or other parts of machinery.
• Installed new systems, replacement parts and components to maintain proper operation.
• Diagnosed equipment malfunctions and performed repairs to restore equipment and maintain uptime.

• Established and enforced clear goals to keep employees working collaboratively.
Maintained operating schedules to provide effective coverage for key areas and
achieve objectives.
•Created training manual for all employees to use as reference guide for their
respective work areas.
•Interviewed applicants, recommended individuals for hiring and evaluated staff
performance.
•Reduced process gaps, effectively managing and training 22-30 employees on
best practices to ensure optimal productivity.
•Ensured all manufacturing and performance goals were met during operations
• Conducted employee evaluations and reviews
•Spent six weeks in Zossen, Germany training on process, control room and machines

• Complied with company policies, objectives and communication goals.