JOEL F. CRUZ GOMEZ
Calverton,NY
Overview
19
19
years of professional experience
Work History
Sr. VALIDATION ENGINEER (Consultant)
Empower Pharmacy
East Windsor
06.2024 - Current
- Manage and execute several validation projects
- Participate in the preparation of URS, IQ/OQ and PQ Protocols and Summaries Reports of Compressed Air, Clean Steam & Nitrogen, to support validation requirements of the Laboratory and Manufacturing area and equipment
- In Charge of Compressed Gases Analytical Sampling.
VALIDATION SPECIALIST
THERMOFISHER (Carlton National)
Plainville
09.2023 - 12.2023
- Participated in and executed validation of highly automated equipment and process in compliance with company and regulatory agencies’ standards
- Participated in the preparation and execution of Kneat GX Commissioning, Validation Plan IQ/OQ/PQ Protocols and Summaries, to support validation requirements of the Laboratory and Manufacturing Area and equipment’s.
Sr. VALIDATION Consultant
FUJIFILM (MENTOR)
College Station
07.2020 - 09.2023
- Participated in and executed validation of highly automated equipment, utilities, facilities, and process in compliance with company and regulatory agencies standards
- Manage and execute several validation projects
- Participate in the preparation of URS, Change Control, Commissioning, SAT, SIA, Validation Plan IQ/OQ and EMPQ Protocols and Summaries Reports, to support validation requirements of the Laboratory and Manufacturing Area and equipment’s.
Validation Specialist
Johnson & Johnson- Janssen (JC automation)
Vacaville
10.2019 - 12.2019
- Assisted in PLC CPU Modules, HMI, PC, Amplifiers, Motor Drivers and UPS in Korsch 5 replacement
- Participated in and executed validation of highly automated equipment, facilities and process in compliance with company and regulatory agencies standards
- Participated in the preparation and execution of CSV IQ/OQ Protocols and Traceability Matrix document, to support validation requirements of the Tablet Press.
VALIDATION SPECIALIST
FUJIFILM (MENTOR)
College Station
11.2018 - 09.2019
- Participated in and executed validation of highly automated equipment, facilities and process in compliance with company and regulatory agencies standards
- Participated in the preparation and execution of URS, Change Control, Commissioning, FAT, SAT, SIA, Validation Plan IQ/OQ/PQ Protocols and Summaries, to support validation requirements of the Laboratory and Manufacturing Area and equipment’s.
VALIDATION SPECIALIST
BRISTOL-MYERS SQUIBB (Validation Engineer Group)
Humacao
08.2017 - 03.2018
- Participated in and executed validation of highly automated equipment, facilities and process in compliance with company and regulatory agencies standards
- Participated in the preparation and execution of CSV IQ/OQ Protocols and Traceability Matrix document, to support validation requirements of the granulation, compression and Coater Machine Area and equipment’s.
SENIOR MANUFACTURING ASSOCIATE/FERMENTATION AREA LEAD & ACTIVE MANAGER/VALIDATION
AMGEN MANUFACTURING LTD
07.2005 - 07.2016
- Provide guidance during the planning and definition phases to develop a validation approach commensurate to the risk level assigned to the systems across teams and with outside agencies including Federal Drug Administration while preparing the CSV execution in EBR, WERUM and SAP
- Coordinated investigations into failures to meet acceptance criteria and determine appropriate corrective actions
- Review and approved all validation documentation and oversee the execution of validation protocols
- Assist in the development of MES PAX and SAP troubleshooting including recipes configuration systems changes to meet business requirements.
Timeline
Sr. VALIDATION ENGINEER (Consultant)
Empower Pharmacy
06.2024 - Current
VALIDATION SPECIALIST
THERMOFISHER (Carlton National)
09.2023 - 12.2023
Sr. VALIDATION Consultant
FUJIFILM (MENTOR)
07.2020 - 09.2023
Validation Specialist
Johnson & Johnson- Janssen (JC automation)
10.2019 - 12.2019
VALIDATION SPECIALIST
FUJIFILM (MENTOR)
11.2018 - 09.2019
VALIDATION SPECIALIST
BRISTOL-MYERS SQUIBB (Validation Engineer Group)
08.2017 - 03.2018
SENIOR MANUFACTURING ASSOCIATE/FERMENTATION AREA LEAD & ACTIVE MANAGER/VALIDATION
AMGEN MANUFACTURING LTD
07.2005 - 07.2016