Pharmacy Technician Software

Pawel Ibek

914-***-**** Coram, NY *********@*****.***

SUNY Stony Brook University Graduated Dec. 2016 Bachelor of Science: Developmental Genetics

SKILLS

Blue Mountain RAM; Kaye Software; Trackwise; Microsoft Office; BCS (Batch Control System); Sani-Matic software; SAP software

PROFESSIONAL EXPERIENCE

Validation Specialist Feb 2019 - Present American Regent, Inc

●Authored and executed; Performance Qualification (PQ), Installation Qualification (IQ) and Operational Qualification (OQ) protocols.

●Use of the Kaye Validator system to run temperature mapping studies on a variety of manufacturing and laboratory equipment. Programming templates for protocols.

●Use of Datatrace equipment to perform temperature verification studies on controlled areas and laboratory equipment.

●Collaborated with the manufacturing department to design and develop cleaning procedures and processes for cGMP equipment used in the manufacture of pharmaceutical products.

●Performed monthly maintenance validations on autoclaves, depyrogenation tunnels, and leak detection equipment.

●Developed and assessed CAPAs, change controls, deviations, and investigations as they pertain to validation.

●Wrote and edited SOPs to account for new equipment as well as improving past validation procedures.

●Calibrated instruments used for temperature mapping and maintenance validations for a Wilco leak detection equipment.

●Collaborated with multiple departments to schedule, perform, and assess the results of various validation activities with no supervision.

●Maintaining physical records of the validation departments and uploading relevant information to Blue Mountain RAM.

Manufacturing Technician June 2017 - Feb 2019 Kedrion Biopharma

Performed equipment operation/setup/breakdown/sanitation in a biologics processing equipment for plasma derived biopharmaceutical products.

Prepared buffers and solutions using chemicals while acknowledging material safety data sheets.

Took inventory of PPE/chemicals/materials and put in requests as was necessary.

Collected samples and tested pH/conductivity and submitted to laboratory departments for testing.

Worked alongside validation and automation engineers and other cross-functional teams completing a variety of

necessary tests for process/equipment validation during PPQs (Process Performance Qualification Protocols).

Performed daily calibration of equipment, pH/conductivity meters, and scales.

cGMP compliant, good documentation practices, and qualified to operate in class C & D environments while following proper gowning procedures.

Performed daily, weekly, and monthly room and equipment sanitizations.

Pharmacy Technician Oct 2013 - June 2017 Stop and Shop

Helped healthcare providers and patients through daily interactions and phone calls by answering questions, and filling requests.

Operated extensive software covering a wide variety of applications to order medications and process insurance claims.

Performed billing procedures by recording and handling cash flow.

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