William Tunstall
Earleville,MD
Summary
As a Senior Formulation operator, I oversee the daily Weigh & Dispense and Granulation operations supporting multiple products and processes across a multi-billion-dollar pharmaceutical site. I manage junior operators as a lead trainer for solid oral dose formulation weigh & dispense and granulation as needed. I am the area SME for quality investigations, raw material logistics, batch processing equipment set-up, repair, and electronic batch record systems. I aim to create a positive, comfortable, and organized work environment for all members of my team and work as a highly experienced resource to build efficient processes and confident high performing teams.
Overview
30
30
years of professional experience
Work History
Sr./Lead Process Operator
AstraZeneca Pharmaceuticals
Newark , DE
09.2012 - Current
- Responsible for weighing and management of flow of raw materials for site solid oral dose process areas using SAP, PASX, and Microsoft office tools
- Formulation lead trainer and SME for Weigh and Dispense, area Quality, and raw material investigations, PASX, SAP, PIT (Powered industrial truck) trainer and qualified granulation operations trainer
- Qualified in multiple production areas routinely performing critical weighing operations, delicate equipment set up, and managing equipment using PASX electronic batch record system
- I perform daily area and equipment inspection readiness, logbook reviews, batch documentation and review, critical API weighing and scale calibrations
- Routinely I work with IQC, supply planning, Formulation management and Automated storage/ finished goods warehouses to procure raw materials, manage restrict release and delivery, schedule 40+ batch multiple product weighing campaigns weekly of more than 20,000+ kilograms and manage delicate manufacturing processes utilizing CGMPs, and established SOPs
- I routinely identify SOP updates, equipment upgrades and design, batch record improvements and implementation using Microsoft applications and Lean initiatives
- Created area job aides, work standards, process SOPs, training tools, videos and 5s area organizational standards for multiple processes and production areas
- I routinely assist and investigate process deviations and equipment failures working with QA, maintenance, management, process investigators to perform root cause analysis and provide solutions
- From 2017 through the present, I’ve collaborated with engineers and technicians to perform building design and start up in a 100-million-dollar solid oral dose formulation expansion completing equipment installation, equipment IQ\OQ testing, and process start up validation
- Selected by Formulation management as an area lead to champion the transition from aging Central Weigh facility to the new Weigh & dispense areas, set up consistent operations and train new workforce
- Identified and worked with engineering, quality, and MES teams to implement major improvements to site weighing procedures creating extraordinary efficiency, accuracy, and have continuously made significant process improvements
- Chosen by site leadership for Lean cross functional project as area lead for team building event at IPR site to learn and identify opportunities for site and process improvements.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Organized and detail-oriented with a strong work ethic.
- Self-motivated, with a strong sense of personal responsibility.
Manufacturing Technician 3
Medimmune, LLC. / AstraZeneca Biologics
02.2011 - 09.2012
- Live Virus liquid filling operations technician III performing all process steps of production operations - working with hazardous materials in difficult work environments
- Performed complex delicate liquid manufacturing equipment set up, sterilization and repair and production operations in class 100 – 100,000 work environments
- Managed hazardous live viruses in a safe and responsible manner per SOPs and OSHA safety procedures
- Executed filling and Blending operations and projects with minimal instruction and management oversight
- Authored and edited standard operating procedures and updated batch documentation to support site OEE and LEAN improvements
- Performed potency calculations and documented production operations according to regional batch requirements using state of the art equipment and processes
- Performed delicate equipment maintenance, repair, processed work orders and trained junior technicians in production areas
- Managed temporary workforce training and daily assignments and production schedule
- Area subject matter expert on containment and environmental monitoring, sterilization operations, deviation investigations and Aseptic gowning
- Consistently worked with Engineering and Non-manufacturing personnel to achieve goals and ensure production targets were met accurately and on schedule
- Utilized TDMS, LIMS, and SAP to perform area documentation, environmental testing, and batch management
- Created 5s standards, area schedules and managed raw material flow from goods receipt through Aseptic class 100 process areas into cold storage facility
- Observed absence of an emergency response team at the Philadelphia site and worked with site leadership to establish teams and provided training, operations experience and helped procure area specific equipment to assist in an emergency
- This work set site manufacturing personnel up for success to respond to multiple incidents including safe extraction of a pregnant colleague after a fall.
Sterile Process Operator (Manufacturing - MERREM)
AstraZeneca Pharmaceuticals
08.1999 - 12.2010
- Assembled, disassembled, operated, repaired, and maintained pneumatic sterile powder dosing equipment under strict class 100 conditions daily under strict 18-hour production schedule providing drug of last resort life-saving antibiotic
- Set up and continuously improved performance on delicate pneumatic high-speed production and visual inspection machines with critical tolerances
- Fulfilled production targets with excellent mechanical aptitude and documentation accuracy
- Reacted to dynamic production needs and schedule changes with flexibility, dedication, and short notice overtime to fulfill site OEE goals
- Managed hazardous Chemicals and Active Pharmaceutical ingredients in a safe and responsible manner per SOPs and OSHA safety procedures
- Performed filter integrity testing, and extensive environmental monitoring as needed
- Cleaned, sanitized, maintained, monitored, and supplied production areas
- Provided training, leadership and direction to junior operators and packaging personnel to ensure site production goals and LEAN initiatives were met
- Operated independently and on teams in multiple roles with little or no supervision in a focused and dynamic production environment
- Assisted QA/Engineering and contractors with validation of new equipment and processes routinely to meet industry standards and ensure LEAN goals were met
- Assisted multiple warehouses with raw material deliveries and inventory control to isolated antibiotic manufacturing facility utilizing SAP and established containment controls
- Aseptic core trainer, and area SME on containment, Quality, and sterile gowning
- Managed emergency provisions and shipment of life saving medicine as area lead on evening shifts, as necessary
- Championed batch record, document control and archiving throughout closure of facility after patent expiration.
Packaging Operator (Tablet/ Blister/ liquids/ vial/ sterile vial)
AstraZeneca Pharmaceuticals
08.1997 - 08.1999
- Set up, operated and maintained various automated high-speed processing equipment
- Tracked and kept detailed records for productivity and yields
- Inspected, transferred, evaluated, and managed flow of bulk products
- Assisted in developing meaningful metrics and training regimens for the areas
- Cleaned, maintained, monitored, and supplied production areas
- Supported daily and weekend overtime with a flexible schedule due to process constraints and production needs
- Assisted and monitored installation of automated pneumatic production robots for liquid vial and ampule transfer and packing
- Performed line set up and assembly of complex automated tablet fillers, cappers, induction sealers and label machines.
Shipping/Receiving supervisor
E.A.R. Specialty Composites
07.1994 - 08.1997
- Operated in various leadership roles for energy control materials manufacturer
- Operated hydraulic and pneumatic presses, mixers, blenders, and sprayers for laminating, die-cutting and compositing with facings and substrates
- Operated Thin-sheet casting lines for urethane and vinyl foam manufacturing
- Performed Injection, compression, and transfer molding for solid vinyl materials, dampening foam, isolators, and cushioning parts
- Performed repairs, line changeovers, packaging, planning, and shipping/receiving
- Performed in various roles supporting ISO-9001 certification and quickly promoted to leadership role responsible for Shipping, receiving teams and control of inventory management, production planning and order tracking
- Worked daily with major trucking companies to receive raw materials and to ship finished goods to customers
- Managed ordering and delivery of storage trailers and movement of goods between three local warehouses using Roadway, Yellow Freight and 2 - 24’ Freightliner box trucks
- Assisted in the installation and implementation of SAP R3 to control order tracking and inventory management
- Created orders and shipped through Fed Ex and UPS using supplied programs
- Managed staffing and schedule of a fast-paced shipping and receiving office with three warehouses, thirteen loading docks, and 7 direct reports.
Education
Skills
- SAP / Microsoft office
- Lean Manufacturing
- Project management
- Equipment set-up and maintenance
- Aseptic / Process area management
- Root cause analysis
- Level zero investigations
- Communication & Team building
- Electronic batch records
- Emergency response
- Quality standards CGMPs /SOPs
- Validation /startup IQ/OQ/PQ, FAT
- Quality Assurance
References
- Dan Megahan, 1-302-377-0735
- Morris Gordon, 1-610-745-9310
- Joseph Hall, 1-443-553-8112
Timeline
Sr./Lead Process Operator
AstraZeneca Pharmaceuticals
09.2012 - Current
Manufacturing Technician 3
Medimmune, LLC. / AstraZeneca Biologics
02.2011 - 09.2012
Sterile Process Operator (Manufacturing - MERREM)
AstraZeneca Pharmaceuticals
08.1999 - 12.2010
Packaging Operator (Tablet/ Blister/ liquids/ vial/ sterile vial)
AstraZeneca Pharmaceuticals
08.1997 - 08.1999
Shipping/Receiving supervisor
E.A.R. Specialty Composites
07.1994 - 08.1997
Similar Profiles
Kellie SmithKellie Smith
Lead Patient Access Specialist at AstraZeneca PharmaceuticalsLead Patient Access Specialist at AstraZeneca Pharmaceuticals
Lucas LopezLucas Lopez
Formulation Technician at AstraZeneca PharmaceuticalsFormulation Technician at AstraZeneca Pharmaceuticals
Elanur AkdemirElanur Akdemir
Human Resources Specialist at AstraZeneca PharmaceuticalsHuman Resources Specialist at AstraZeneca Pharmaceuticals
Hüseyin TekinHüseyin Tekin
Field Scientific Leader at AstraZeneca PharmaceuticalsField Scientific Leader at AstraZeneca Pharmaceuticals
Kiauna GasiorowskiKiauna Gasiorowski
Administrative Assistant at R&M Enterprises, Inc.Administrative Assistant at R&M Enterprises, Inc.