JOEL F. CRUZ GOMEZ College Station, TX ad2w7j@r.postjobfree.com 939-***-****

Validation Consulting Protocol Writing Skills Process Analysis VALIDATION SPECIALIST

Quality and compliance professional with over 16 years of experience in the Pharmaceutical and Biopharmaceutical industry. Extensive knowledge overseeing quality, compliance and governance of multiple Validation documents projects, working against SOP’s, PLC and FDA regulatory guidelines. Multilingual communicator with top proficiency in Spanish and English.

CSV Validation

Data Security & Integrity

Utilities & Facilities Validation

Design and Plan Protocols

Safety & Quality Requirements

CFR 11, GMP Standards

Product Transfer

Facility & Utilities Commissioning

Process Analysis

Roots Cause Analysis

Commissioning

Process Validation

PROFESSIONAL EXPERIENCE

FUJIFILM (MENTOR)

Sr. VALIDATION Consultant College Station, TX Jul 2020 – Present

- Participated 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.

• Proficiencies: Problem solving and troubleshooting skills. Coordinates all validation activities by constant communication with affected departments and personnel (team player).

• Accomplishments: Ability to work in a fast-paced environment while supporting multiple and changing priorities. Comply with meeting project objective timelines by successfully planning, tracking, and executing validation projects. Johnson & Johnson- Janssen (JC automation)

Validation Specialist Vacaville, CA October 2019-December 2019

- Assisted in PLC CPU Modules, HMI, PC, Amplifiers, Motor Drivers and UPS in Korsch 5 replacement.

- Participated 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.

• Proficiencies: IQ, OQ, PQ of Compression Machines.

• Accomplishments: Participated in the execution of IOQ, protocols for Compression Machines. FUJIFILM (MENTOR)

VALIDATION SPECIALIST College Station, TX Nov 2018 – Sept 2019

- Participated 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.

• Proficiencies: URS, CC, SAT, VP, IQ, OQ, PQ of Biological Safety Cabinet, Inspection Box, Bio Welder’s, Laboratory equipment’s, IR, Spectrophotometer, Oxygen and Carbon Dioxide Storage and Distribution System, WFI Sub-Loop Distribution System and RODI Generation System.

• Accomplishments: In charge of URS, CC, Validation Plan And IQ/OQ/PQ Protocols executions and Summaries. BRISTOL-MYERS SQUIBB (Validation Engineer Group)

VALIDATION SPECIALIST Humacao, PR Aug-2017 – Mar 2018

- Participated 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.

• Proficiencies: IQ, OQ, PQ of Isolators, Compression Machines, Coaters Machines and Drums Lifters equipment.

• Accomplishments: Participated in the execution of IOQ, protocols for Compression Machines, Coaters Machines and Drums Lifters equipment.

AMGEN MANUFACTURING LTD

SENIOR MANUFACTURING ASSOCIATE/FERMENTATION AREA LEAD & ACTIVE MANAGER/VALIDATION Jul 2005 – Jul 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.

• Proficiencies: IQ, OQ, PQ, Traceability Matrix, process and cleaning validation for Autoclaves, KAYE Validator, Bioreactors, Media Fill, UF/DF and centrifuges. EBR, SAP, WERUM super user. Spectrophotometer, conductivity, pH Meter calibration & validation. Evaluate and calibrate buffer bags and downstream equipment.

• Accomplishments: Participated in the execution of IOQ, protocols for controlled temperature units. Developed and executed CV, IOQ, protocols for CIP skids, Washers and Autoclaves. Also, participate in IQ, OQ and Commissioning for SAP and WERUM System. PFIZER PHARMACEUTICALS, Caguas, PR Mar 1998 – May 2005 Senior Pharmaceutical Manufacturing Operator

• Proficiencies: Oversaw all manufacturing operations to include weighing, granulation, compression, capsule filling, packaging and various others. Optimized and implemented various protocols relevant to the manufacturing area including IQ, OQ, and PQ. Adhered to regulations and instructions detailed in current, up-to-date SOPs. Documented and maintained all records and verified manual entries as a second operator

• Accomplishments: Participated in the protocol development of the swab and rinse method and Micro and Surface Sampling. FERRERO OF PUERTO RICO, Caguas, PR Nov 1997 – Mar 1998 Chemical Operator (CTS Temporary Assignment)

● Proficiencies: Responsible for the proper operations of blending, compression, granulation, and coating. UNIVERSITY OF PUERTO RICO-MEDICAL SCIENCE CAMPUS, Hato Rey, PR Mar 1996 – Nov 1997 Laboratory and Field Technician

● Proficiencies: Performed toxicology tests. Executed PQ for laboratory equipment as well as prepared proposals and scientific reports. Generated purchase orders and received shipments for the laboratory.

● Proficiencies: Participated with the design and execution of laboratory experiments in order to understand the function of genes. EDUCATION & CERTIFICATIONS

MASTER OF BUSINESS ADMINISTRATION UNIVERSITY OF TURABO Gurabo, PR, 2002 BACHELOR OF SCIENCE IN MARINE BIOLOGY UNIVERSITY OF PUERTO RICO Humacao, PR, 1998 CERTIFICATE OF SCIENCE IN BIOPHARMA PROCESSING NIBRT Ireland, 2013 CERTIFICATE IN FERMENTATION METHODS & SCALE-UP STRATEGIES PENN STATE UNIVERSITY University Park, PA 2005 CERTIFICATE IN UPSTREAM BIOPROCESSES FOR BIOTECHNOLOGY MANUFACTURING UNIVERSITY OF PUERTO RICO Mayaguez, PR 2011

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