Timothy Wilcox
Kannapolis,NC
Summary
I'm a knowledgeable, experienced Bio-process technician. With extensive knowledge and experience working with PFS and vial filling equipment. I'm enthusiastic about working with people and teams of all backgrounds to transform pharmaceutical companies into more productive processes.
Creates success by learning new processes, maintaining professional environments and taking the lead in development of procedures for the process. My areas of expertise include leadership qualities, aseptic filling operations, Vial Washer, Depyrogentation Tunnels, Filler/Isolators, troubleshooting, preventive maintenance, machine operation and mechanically inclined.
I feel with my experience and training would qualify me to be an asset to a company that aims for Excellence, Integrity and Relationships.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Expert Filling Technician
Eli Lilly
RTP, Durham, NC
01.2022 - Current
- Assists the Supervisor with leading Fill Team per Manufacturing Standard for Operational Excellence
- Helped improve process by implementing successful solutions to repetitive issues
- Operate Optima Isolator to fill syringes according to specifications during validation and start-up for accuracy and quality control
- Assists with performing routine maintenance on filling equipment
- Monitor machinery performance and reported malfunctions or breakdowns in a timely manner
- Follow all company policies and procedures regarding safety, cleanliness and quality assurance standards
- Clean equipment and area as needed to ensure safe working environment and FDA ready
- Collaborate with other departments to ensure efficient workflow throughout entire manufacturing process
- Dispose of hazardous waste properly in accordance with environment regulations
- Provides support and guidance in training new technicians on proper operation of the Optima Isolator and filling process
- Assists in qualifying Optima Isolator for PQ, IQ and OQ
- Conducts and assisted in the hiring process for new technicians and associates
Team Lead
Biogen Parenteral Facility
RTP, Durham, NC
07.2021 - 01.2022
- Leads shift when supervisor is unavailable, actively leads shift exchanges, works independently with minimal direction, coordinates activities and daily schedules with cross-functional areas
- Executes Aseptic manufacturing filling process steps within 'A' space and manufacturing support activities, monitoring the process against the batch record SLR and control systems
- Coordinates and leads process steps as required, serving as SME
- Documents, records and reviews cGMP data and information for processing steps or equipment activities, following standard SOP's
- Develops and revises documents as needed, key documentation includes cGMP, batch records, SLR's and equipment logbooks
- Participates in training activities, provides training to other associates and shares knowledge with others.
Senior Fill/Finish Lead
Glenmark Pharmaceuticals / Start-up
Monroe, NC, NC
09.2016 - 07.2021
- Setup, changeover, operate, troubleshoot Groninger Isolator/filler, Depyrogenation tunnel and Vial Washer
- Assisted contractors with installing Groninger equipment during initial start-up phase
- Participated in Validation of all Groninger and Snowbell equipment, ie: IQ, OQ and PQ
- Executed aseptic filling process techniques within aseptic environment
- Formulation, filtration and prepare instruments for sterilization procedures
- VHP, SIP, CIP and Cool Zone Sterilization cycles
- Worked on eliminating issues on all machinery
- Assists and covers for supervisor with shift activities, team management and motivation of team members
- Assists with CAPA's, batch record review, investigations, Scale Ups, Media fills, Exhibit batches and participated in mock and successful FDA audits
- Integrated process improvements to increase overall workflow.
Maintenance Technician
Merck
Durham, NC, NC
03.2012 - 05.2016
- Setup, changeover, operate and troubleshoot Bausch and Stroebel Isolator/filler, Depyrogenation tunnel and Vial Washer
- Aseptic filling operator in aseptic process environment, trained in visual vial 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
- Assists Validation with protocols, IQ, PQ and OQ
- Coordinated with Bausch and Stroebel Isolator vendors to prepare for training, large system installations and complex repairs
- Routinely inspected plant equipment for signs of wear or malfunctioning parts.
- Per EBR ran CIP, SIP, Depyrogentation Tunnel Cool Zone Sterilization via Delta-V and MES systems
- Performed PM's to ensure proper machine operation for production.
- Maintained accurate records of all maintenance activities performed.
- Provided technical support to production staff for machine troubleshooting needs.
Supervisor
Uniboard / Start-up
Moncure, NC, NC
04.2009 - 03.2012
- 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 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
- Conducted employee evaluations and reviews.
Utility Operator
Degussa
Greensboro, NC, NC
06.2006 - 02.2009
- Operated fork trucks safely and reported process upsets, chemical releases and security events to appropriate departments
- Observed gauges, recording instruments and flowmeters to maintain specified conditions
- Tested product samples for specific gravity, chemical characteristics, pH levels, concentrations and viscosities, mixed batches for processes.
- Inspected equipment regularly for signs of wear and tear or damage and performed necessary maintenance
- Monitored gauges recording instruments and flowmeters to maintain specified conditions
- Tested product samples for specific gravity, ph levels, concentrations and viscosities
- Monitored and recorded data related to water flow, pressure, temperature and other variables to ensure optimal functioning of the utility system
- Performed preventive maintenance on equipment to reduce downtime and improve efficiency
- Utilized a variety of tools such as wrenches, screwdrivers, drills, saws grinders, etc for repairs or adjustment to equipment
QA Inspector
Armacell
Mebane, NC
07.1999 - 04.2006
- Analyzed data to identify trends or patterns of defective parts.
- Monitor packaging and shipping of products to ensure customer specifications are met
- Inspected parts for defects
- Assisted in the development of inspection criteria for new products and processes
- Provided feedback to engineering and development teams regarding product performance against expected results
- Analyze data to identify trends or patterns of defective parts
- conducted process audits to ensure compliance with established standards
- Documented non-conformance issues using standard forms and Windows database software
- Utilized measuring tools such as calipers, micrometers and gauges
- Participated in root cause analysis investigations
Education
Some College (No Degree) - Biology
Alamance Community College
High School Diploma -
Alfred E. Smith High School
Skills
- Positive Attitude
- Aseptic Techniques/Aseptic gowning
- Bausch & Stroebel Fillers (12 needles), Depyrogenation Tunnels and Vial Washers
- LSI lyophilization freeze dry systems
- Terminal Sterilizer Autoclave
- Pharmaceutical Packaging Systems
- Rota PFS (Pre-filled syringes) machines
- Mes, Delta-V, LIMS, SAP and Blue Mountain
- Environmental Monitoring
- CIP, SIP, VHP and CZS (Cool zone sterilization)
- Validation IQ, OQ and PQ
- Mechanically Inclined
- Excellent with tools / power tools
Certification
- Supervisor Certification from CAI in Raleigh, NC
- CGMP and GDP certifications
- Yellow Belt
- Environmental Monitoring
- Lock/Out Tag/Out
- Arc Flash
- Aseptic Gowning certification
Timeline
Expert Filling Technician
Eli Lilly
01.2022 - Current
Team Lead
Biogen Parenteral Facility
07.2021 - 01.2022
Senior Fill/Finish Lead
Glenmark Pharmaceuticals / Start-up
09.2016 - 07.2021
Maintenance Technician
Merck
03.2012 - 05.2016
Supervisor
Uniboard / Start-up
04.2009 - 03.2012
Utility Operator
Degussa
06.2006 - 02.2009
QA Inspector
Armacell
07.1999 - 04.2006
Some College (No Degree) - Biology
Alamance Community College
High School Diploma -
Alfred E. Smith High School
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