Stephen Renken
Lillington,NC
Summary
Experienced pharmaceutical technician with critical thinking skills that have helped me navigate 3 different Pfizer products so far. Additional skills that I have garnered during my time as a technician include but are not limited to SOP writing, troubleshooting equipment, proficient in SAP, P-DOCS, P-Logs, and leadership skills. I have ten years of experience as a firefighter and spent six years in the US Army.
Overview
34
34
years of professional experience
Work History
Downstream Technical Operator IV
Pfizer
08.2024 - Current
- Taking product that is moved over from Upstream via a Harvest transfer line and taking that product through several engineering, and PPQ runs. The downstream process has exposed me to the following processes and equipment. Affinity/Pro-A skid that moves the product along a packed column and moves into a 1000L Sum. From there the product moves through a Depth filtration system into another 1000L Sum. The product is then moved through the AEX skid which will run across a second column ending up in a 1000L sum. At this point the product will move through Viral Filtration and move through the wall into a 1000L Sum. That 1000L Sum will be moved into the Post Viral suite for UF/DF and Final Fill. Follow the sample plan for procuring samples to check pH/conductivity for proper levels. Operate equipment in a safe manner.
Upstream/Downstream Technical Operator IV
Pfizer
11.2023 - 08.2024
- As the Technical Operator IV, I was charged with Lead responsibilities to do shift transfer, shift notes, and leading Tier for our team. Write/review/revise GMP documents to include SOP’s, master batch records, specifications, and other applicable cGMP documentation for manufacturing. Maintains GMP records to comply with regulatory requirements and assists with in-process development testing. Outline manufacturing suite designs for all areas of processing.
Bio Process Technician III
Pfizer/GTx2 Downstream
10.2022 - 10.2023
- Operate equipment in a safe manner per SOP and MBR. Maintain communication with Upstream to receive harvest. Affinity skid and column, AEX skid and column, AEX Dilution, Fraction Bags, Viral Filtration, UF/DF via Delta V. Utilize SAP and LIMS as needed for process. Communicate with coworkers, leads, and supervisors. Assemble and disassemble parts per MBR, job aid, and SOP. Procure in-process samples to check pH/conductivity for proper levels.
Firefighter/EMT-B
Town of Clayton
07.2021 - 10.2022
- Respond to calls for fires, accidents, and other emergencies. Conduct training sessions and present various public-education programs. Create incident reports according to Standards of Protocol. Perform fire and safety inspections of residential and commercial properties. Maintain equipment in optimal working order and perform light vehicle maintenance as needed.
Aseptic Filling Technician
Novo Nordisk
01.2021 - 07.2021
- Filling insulin and media preparations under aseptic conditions and operation of inspection equipment to achieve production goals. Work in a safe and environmentally responsible manner. Operating, monitoring and controlling equipment, systems and processes associated with the Vial/Cartridge filling and inspection lines. Maintaining aseptic areas and performing sanitizations and environmental monitoring. Actively participate in and support event response. Reviewing and authoring Standard Operating Procedures (SOP’s) and other documents as required. Assist during equipment maintenance including restoration of lost function, predictive and preventative maintenance. Train fellow employees in areas of expertise and aggressively learn systems and equipment outside of own expertise. Recording/reviewing of production data in BPR’s and associated forms.
Packaging Technician (Contract)
Corestaff at Novo Nordisk
10.2020 - 12.2020
- Setup, operate, monitor & control equipment, systems & processes. Execute production schedule to achieve production goals. Handle labeling & components correctly; transferring, counting, FIFO, returns, etc. Actively participate in & support event response. Identify, report & resolve quality issues. Execute and/or assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance. Train fellow employees in areas of expertise & aggressively learn systems & equipment outside of own expertise.
Solutions Production Technician
Pfizer
02.2019 - 06.2020
- Responsible for weighing, measuring, and charging ingredients and inspecting solutions for complete dissolution. Responsible for the pre/post cleaning of all equipment necessary for batch manufacture. Responsible for maintaining proper process parameters (i.e. mixing time, speed, temperature and any other applicable variables. Prepares tanks, cleans tanks, and area related equipment before and after solution manufacturing. Weighs materials, cleans and sets up test filter, withdraws samples, performs some testing (ph, conductivity, oxidizable substances, etc) as needed for solution manufacture. Performs in process pH checks for solutions and makes adjustments as needed.
Fractionation Technician
Grifols Therapeutics Inc.
06.2018 - 02.2019
- Assisted in the manufacturing of pharmaceutical products in accordance with SOP and batch record specifications. Process Plasma up to Fraction V paste step. Prepare Buffers for process to be used in process steps. Have knowledge use of Microsoft and some training of a DCS program. Operating under guidelines of a cGMP facility. Operate and perform light maintenance on Sharples Centrifuge and Westphalia Centrifuge.
Cable Technician II
Charter Communications
11.2016 - 09.2017
- Install and repair complex wires and cables. Proficient with computers, diagnostic equipment, and complex machines. Use diagnostic skills to establish the root cause of technical issues and devise a solution for repair. Prepare documentation to keep track of parts used, time spent at a customer's house, and repairs. Coordinate with customers to communicate the actions being taken during repair or installation.
Firefighter II/EMT
Town of Cary
04.2007 - 03.2014
- Responded to calls for fire and health emergencies. Performed first aid and assisted in life-saving efforts. Conducted training for 20 new staff members. Assisted in maintenance of emergency vehicles and equipment. Documented incidents according to Standards of Protocol.
Infantry Squad Leader/Preventive Medicine Specialist
United States Army
06.1991 - 10.1997
- Paratrooper 82nd Airborne Division. Infantry Team Leader- supervised and led a 3 man team on missions including land navigation and securing the company perimeter. Preventive Medicine Specialist-part of the team charged with studying and preventing the spread of infection and disease within the Army, conduct and assist with preventive medicine inspections, surveys, and laboratory procedures, supervise small preventive medicine services or units and organize water and food sanitation programs, charged with overseeing programs to collect and analyze any pertinent data, and supervising the administrative functions of any preventive medicine activities, such as record-keeping.
- E-4/SPC
- Honorably Discharged
- Primary Leadership Development School-Commandant’s List Graduate
Education
Biowork Certification Program -
Johnston County Community College
Smithfield, NC01.2014
Skills
- Trainer
- Leadership
- Detail oriented
- Collaborative teamwork
- Equipment operation
- Quick Learner
Timeline
Downstream Technical Operator IV
Pfizer
08.2024 - Current
Upstream/Downstream Technical Operator IV
Pfizer
11.2023 - 08.2024
Bio Process Technician III
Pfizer/GTx2 Downstream
10.2022 - 10.2023
Firefighter/EMT-B
Town of Clayton
07.2021 - 10.2022
Aseptic Filling Technician
Novo Nordisk
01.2021 - 07.2021
Packaging Technician (Contract)
Corestaff at Novo Nordisk
10.2020 - 12.2020
Solutions Production Technician
Pfizer
02.2019 - 06.2020
Fractionation Technician
Grifols Therapeutics Inc.
06.2018 - 02.2019
Cable Technician II
Charter Communications
11.2016 - 09.2017
Firefighter II/EMT
Town of Cary
04.2007 - 03.2014
Infantry Squad Leader/Preventive Medicine Specialist
United States Army
06.1991 - 10.1997
Biowork Certification Program -
Johnston County Community College
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