VICTOR RODRIGUEZ

787-***-****/787-***-**** • ac4hyz@r.postjobfree.com

Chemical Engineer ● Validation Analyst ● QA/QC Laboratory Analyst

Results-driven reliable professional and highly effective with more than 7 years of progressive experience providing successful validation process and laboratory improvement on diverse Chemical, Medical Device & Pharmaceutical industries. Leverage strong communication and leadership skills to spearhead multi-disciplinary teams dedicated to achieving the corporate mission. Proven ability to critical decision-making, coordination of multiple task assignments and high level of organization.

EDUCATION & CERTIFICATION

B.S. Chemical Engineering, Polytechnic University of PR

B.S. Industrial Microbiology, University of PR, Mayaguez Campus

MS Environmental Chemistry (39 credits approved)

SELECTED SKILLS

Teamwork & Leadership

Interpersonal Communication

Supervision

Analytical Problem Solving

Audits / Investigation Leadership

Trend Analysis

Training / Development

ISO,cGMP, OSHA knowledgeable

Regulatory & Compliance Efforts

Fully Bilingual (English/Spanish)

Analytical lab instrumentation trained (HPLC, GC, AAS, FT-IR)

Self-learner

Self-motivated

PROFESSIONAL EXPERIENCE

Amgen Manufacturing Limited (AML), Juncos, PR • September 2015 – Present

SENIOR VALIDATION SCIENTIST / COMMISSIONING & QUALIFICATION SPECIALIST

Provide Consulting and Support to the Commissioning and Qualification of Enbrel SFP2 and Repatha Projects Commercial Tech Transfer to Manufacturing Facility. Support the RV, IV, OV and Environmental Monitoring logistic.

Inspect physically and documentation of P & ID instrumentation for the RV program prior to installation.

Develop Environmental Qualification Plan for the Validation of Classified Rooms.

Develop Risk Assessment protocols, based on FMEA and PrHA, per AHU for classified rooms.

Develop and execute media fill protocols for isolator filling process in ISO 5 classified conditions.

Develop PQ protocols for the static “At Rest” and dynamic “In Operation” new sampling points in classified areas.

Revised IV documentation for the Installation of Chromatography Columns.

Revise and develop IQ, OQ, PQ, IOQ documents in the EDMQ system for approval.

Introductory training in Lean Six Sigma for the QA Validation Aseptic Process team.

Execute protocol addendums, Facility Qualifications,

Execute Spray Ball Coverage Test, SIP, PT recipes, Smoke Tests, Air Visualization Studies (AVS), Media Fills.

Merck Sharp & Dohme (MSD), Barceloneta/Arecibo, PR • June 2014 – June 2015

RECORD MANAGEMENT AND DECOMMISSIONING ENGINEERING SPECIALIST

Provide logistic in the decommissioning of MSD Records Management for the QO, Safety, HR and Finance departments. Review batch record elements (e.g., MP, PCR), Validation Protocols, Method Transfer Protocols for their retention and holding times based on Legal Hold status.

Acting Team Leader for the Critical Record Retention of the Medical and Human Resource Records.

Prepare inventory for the Master Archive retention list for documents to be retain by Merck in Iron Mountain.

Prepare inventory for the destruction of documents past due there retention time not on Legal Hold.

Helped prepare decommissioning plan and checklists for execution of electronic critical GMP equipment.

Worked within EHS department preparing PSM, PSSR, CC (MOC) documents among others for equipment decommissioning

Prepare the AIQ protocol for the disentanglement of the IT system of Arecibo and Barceloneta site.

Victor Rodriguez • Page 2 • ac4hyz@r.postjobfree.com

Department of Education, Utuado, PR • August 2006-May 2014

HIGH SCHOOL MATH TEACHER

Perform diverse educational functions in support of the school overall performance and student achievement.

Prepare all material lectures, assistance to classroom and evaluation of over 120 students per semester.

Prepare instructional and demonstrative classes for high school students 10th to 12th graders.

Coordinate with Social Workers, Counselor and Special Education Teacher for students with cognitive problems.

Elaborate advanced programs for gifted students for the Advanced College Board Program.

Worked off school time with basketball and volleyball teams as coach for varsity team.

Abbott Company, Jayuya, PR • February 2004- March-2006

CHEMICAL LABORATORY ANALYST II

Provide technical/analytical support to the chemistry laboratory. Liaise with unit operations supporting the Solid Dosage area regarding process deviations and non-conformances to identify root causes, track corrective actions status and report deviation related issues. Coordinate audits investigations for Out of Specifications (OOS) results.

Performed effective environmental monitoring to clean rooms for possible pre and post contamination of active product compliance and report to senior management and report possible root of contamination.

Performed QA/QC review and calculations on chemical procedures and analysis to determine effectiveness of production (Product potential by HPLC, Correct Weight, Dissolution in Human System by Dissolution Bath)

Researched, retrieved, validated, reconciled, and analyzed potential deviations to ensure regulatory compliance with cGMP, GDP and GLP.

Trained and worked in Wet Chemistry and Raw Materials techniques (Heavy Metals, KF, ID of raw materials by titration, ROI, Weight difference, Thin Layer Chromatography (TLC), Polarimeter).

Trained and worked with spectrophotometer techniques for identification (UV-VIS and FT-IR Instruments).

Experience with Analytical Instrumentation (GC, pH meter, analytical balances, Dissolution, Atomic Absorption (AAS))

Water sampling and monitoring for TOC, Chlorine, Arsenic by filtration and titration techniques.

Preparation of technical Laboratory reports, OOS Reports and Deviation reports for investigation and CAPA procedure.

Kratos Technologies, Arecibo, PR • June 2002- December 2003

VALIDATION ANALYST

Served in the Validation Department Area to implement, certify and qualify Active Pharmaceutical Ingredient (API) chemical process, Clean Room Operation and Certification Process Validation, Implementation of new Preventive Maintenance of utilities by computer software.

Responsible for directing and validating all aspects of the Clean Room Certification/Qualification of HEPA filters by RCS and MAS-100 air samplers during Consent Decree at Schering Plough, Manati, PR. Participated in the technical report writing for the Installation Qualification (IQ) and Operation Qualification (OQ) of the new HEPA filter system. Developed and revised the new-implemented standard operating procedure (SOP) of the Clean Room Certification Program. Recorded environmental data to determine filter effectiveness. Worked with Project Management Group to promptly address the findings, implement recommendations, and document results and actions taken. Developed, coordinated, and conducted trainings inside clean room area (Scrubbing, Gowning).

Team Member of the validation and execution of API Netilmycin Chemical Plant Process Validation and Qualification during Consent Decree at Schering Plough at Manati, PR. Investigate step by step procedure to assure Validation of each Unit Operation Qualification. Monitor instrument functionality and notify deviations during 4 shifts, 24/7 operation. Led root cause failure investigations, audits and inspections; provided recommendations and created effective action plans for each step. Sampled, analyzed and validated the Cleaning Operation per unit operation and generated final Summary Report and Protocol with the Validation Specialist for API Process Validation.

Team Member of the Continuing Asset Reliability Solution (CARS) project at Pfizer, Arecibo PR. Investigate and corrected preventive maintenance of all utilities and instrumentations in the plant. Optimized performance through the development and implementation of safety and environmental compliance systems and controls (Standard Operating Procedures, Documented Practices, Preventive Maintenance and tracking tools).

Victor Rodriguez • Page 3 • ac4hyz@r.postjobfree.com

Dupont Pharma, Manati, PR • December 2000- June 2002

ASSOCIATE SCIENTIST (MICROBIOLOGY AREA)

Provided technical and analytical support to the Microbiology Laboratory and Pharmaceutical Operation area with investigations and process analysis. Liaison between Microbiology laboratory and Manufacturing area (Parenteral and Solid Dosage) for process deviations and non-conformances in order to identify root causes, track corrective actions status and report deviation related issues. Coordinate audits investigations for Out of Specifications (OOS) results.

Maintained and monitored process records, update daily control devices operation performance databases and the emission calculations to ensure air compliance. Monitored test execution for adherence to environmental and safety requirements.

Trained in the Aseptic and Non-Aseptic Areas (Parenteral Manufacturing for lyophilization vials and ampules) for Viable Particle (VP), Non-Viable Particle (NVP) monitoring (MAS-100, RCS, Climet), personnel and area surface monitoring by Rodac contact plates. Trained for gowning and hand scrubbing of class in class 100 Clean Room Area.

Experience with biological indicators, Bio burden, Water Monitoring (WFI, DI, and PW) for Total Count, Bacteriological Endotoxin Test (BET) by Gel Clot and Chromogenic Technique using Limulus Amebocyte Lysate (LAL). Sampling of coliforms in production areas by swabs technique. Determination of pyrogen by Staphylococcus Aureus strips.

Monitoring of Nitrogen and Clean Compressed Air system with by Impingers systems. Trained for testing of Sterility and Particle Matter. Experience with Microbiological Identification System using Vitek Computerize System. Mold Identification by scotch tape method. Preparations of equipment, Sterilization (Autoclave Amsco and Finn Aqua) and calibration of balance and pH meters.

Maintained and monitored climate control system and batch records for non-conformance deviations.

Prepare technical laboratory reports for OOS material under investigation and CAPA procedure implementation.

SKILLS

Computer: Autocad, Mathcad, VISIO, Solid Works, MS Office Suite, MS Project, Outlook, Chemcad, EDMQ

Technical/ Regulatory: Current Good Manufacturing Practices (cGMP), Good Documentation Practice (GDP) and Good laboratory Practice (GLP) oriented. Knowledge of standard industry design practices and codes such as ASME, API, ANSI. Extensive experience in OSHA, federal and state environmental regulations (EPA, EQB).

Self-Motivated/Ability to Work with Little or No Supervision: Highly motivated self-starter who takes initiative with minimal supervision.

Willingness to Learn: Enthusiastic, knowledge-hungry learner, eager to meet challenges and quickly assimilate new concepts.

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