Production Operator Manufacturing Associate
Resume:
BRANDON E. FREEMAN
*** ********* **., ****, ** **539
*************@*****.***
Skilled and dedicated manufacturing assembly professional with over ten years of progressive work experience in the laboratory and pharmaceutical equipment supply/ manufacturing industry. WORK EXPERIENCE
SpectraForce – Staffing Agency – Raleigh, NC May 2024 to present CSL Seqirus – Holly Springs, NC
Production Operator
· Complete all production tasks according to GMP, QMS and Environmental Health and Safety (EHS) requirements.
· Operation of aseptic filling equipment in a clean room environment by using aseptic processing techniques, gowning and the correct use of sterilized equipment.
· Completing batch process sheets accurately and in real time.
· Perform and document in-process quality checks and batch process calculations according to Standard Operating Procedure (SOP) requirements.
· Actively participate to improve departmental processes and procedures. Randstad – Raleigh, NC October 2023 to October 2024 Biogen – Research Triangle Park, NC
Manufacturing Associate II (Subject Matter Expert) - Cell Culture / Upstream
· Worked in Media Prep/Buffer Prep where I prepared vessels using DeltaV program to be transferred to tanks.
· Perform processing steps and manufacturing support activities in the Drug Substance facility at Biogen in Research Triangle Park (RTP).
· Perform critical upstream processing activities within Current Good Manufacturing Practice (cGMP) biosafety cabinets including:
o Mammalian cell culture & harvest:
Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors up to 15,000L Performing thaws and splits utilizing Aseptic technique
Dispensing raw materials + batching of media & solutions Corning Life Sciences – Durham, NC
Operations Area Line Lead May 2022 to April 2023
· Provide leadership by directing and supporting Manufacturing Associates in daily operations to ensure smooth product flow.
· Execute production orders successfully.
· Provides troubleshooting for basic equipment faults.
· Works with technicians and engineering on solving problems in areas.
· Lead machine training and complete training assessments for sign offs.
· Ensuring compliance with compliance with all policies, procedures, and ensuring resources are scheduled accordingly per the daily production plan.
Cleanroom Associate I March 2020 to May 2022
· Performs detailed assembly using numerous documented processes involving the use of chemicals, intricate parts, and application of surface treatment.
· Troubleshooting and monitoring output quality and quantity.
· Make adjustments where applicable; alleviating minor jams on production line and auxiliary equipment.
· Read and interpret basic product drawings for the assembly of product and kits.
· Performs routine monitoring and inspection activities per product specifications on products and finished lots.
· Completes production records.
· Packs product and performs final QA check to inspect final pack out.
· Tracks packed volumes and provide data to shift report. Manufacturing Associate I & II January 2014 to March 2020
· Operating all equipment in my area in accordance with shift schedule.
· Making necessary machine adjustments.
· Perform daily housekeeping, waste removal, and end-of-lot line clearance duties.
· Record relevant data onto forms or via electronic data entry.
· Ensure accuracy and good documentation practices.
· Working with tools, cleaning equipment and chemicals following product.
· Assemble, package, label, palletize and stage product.
· Complete electronic inventory transactions.
EDUCATION
NC State University – Raleigh, NC
BioWork Certificate Program
Completed 10/23
Durham Technical Community College – Durham, NC
January 2010 to May 2011
· Technology of Electrical Engineering
Guilford Technical Community College – Greensboro, NC August 2009 to December 2009
· Technology of Electrical Engineering
North Carolina Agricultural and Technical State University – Greensboro, NC August 1996 to December 1999
· Computer Science
· Communication
Northern High School – Durham, NC
August 1992 to June 1996
· High School Diploma
RELEVANT SKILLS:
- Experience using LIMS, SAP, DeltaV, Sincaide
- Experience completing SOPs and documenting work.
- Advanced mechanical aptitude and knowledge of electrical/mechanical equipment
- Excellent reasoning and mathematical skills
- Ability to effectively communicate (written and verbal)
- Understanding of manufacturing run cadence and order of shift activities
- Knowledge of cGMP, safety and operational procedures
- Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)
- Demonstrated leadership and critical thinking skills
Contact this candidate