Operator Forklift

RONALD M MARZOLLA ***********@*******.*** 845-***-****

Summary

Extensive experience in the highly-regulated Pharmaceutical, Biotech, and Consumer Health industry. Expertise in the fermentation and purification processes used in antibiotic and vaccine formulations.

Aseptic and gown certified for clean-room and sterile production. Proficient in environmental sampling and quality assurance and control .

Highly trained in regulatory safety and compliance: FDA, OSHA, EPA, cGMP, SOPs, PMOs.

Recipient of employee recognition awards “Employee of the Month”, “Employee of the Quarter”.

Utilize Plateau training system.

Experience

PFIZER CORPORATION, Pearl River, NY 1977 – Jul 2016

OPERATOR II PRODUCTION DEVELOPMENT, Biotech 2011 – Jul 2016

Prepare, clean, and sterilize fermentation, purification, and batching vessels used in the production of Prevnar bulk vaccine and intermediates. Assemble and perform integrity testing on drums. Aseptic and gown certified. Deliver equipment to vaccine production area.

Equipment includes: Sterile filters, batching vessels, stainless steel drums, drum lifters, formulation tanks, autoclave (trained), SIP, CIP, pH meters, integrity testers.

OPERATOR II, VACCINE FORMULATIONS, Biological Production 1996 – 2011

Biological Formulation Operator II: For bulk Prevnar® vaccine product and intermediates, add raw materials to tanks used in bio-engineering skid process. Handle raw material and product additions, adjustments, sampling, and transfers in a clean-room environment. Aseptic and gown certified. Perform integrity testing of drums, batching tanks, and filters. Perform sterile filtrations of product through automated/manual procedures. Perform environmental monitoring: sterile water sampling, monitor room temperatures, humidity and particle count, bacterial growth. Document batch records and maintain logbooks.

Involved in the start-up, pre-licensing stage of Prevnar® manufacturing, where the production team learned alongside management and continuous process improvement principles were embedded on a daily basis.

Served a 6-month term as Temporary Supervisor. Trained new coworkers on CIP and SIP for sterilizing tanks used in the purification process.

Equipment included: SAS air sampler, Met One particle counter, RODAC plates, CIP, SIP, pumps, pH meter, scales, and mixers.

OPERATOR II, Bulk Fermentation 1977 – 1996

Manually clean and sterilize seed and fermentor tanks and pre-sterilize associated transfer lines between tanks used in the production of various antibiotics.

Weigh and load materials. Inoculate 30-40,000 gal fermentor tanks with 1,200 gal seed tanks to initiate fermentation process. Monitor growth and harvest product to holding tanks. Treat with lyme or salt prior to passing on to refining. Took samples for lab work and to check for contamination. Licensed forklift operator.

Involved in pilot test for Vancomycin®

Trained new employees and conducted skill block checks.

Education / Training

Aseptic Gown Certification

Graduate – Pearl River High School, NY

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