Data Human Resources
Resume:
*** ********* ** ****** • BARCELONETA, PR *****
CELULAR 787-***-****
E-MAIL ****.******.*********@*****.***
Human Resources Specialist
RE: COMPUTER SYSTEM VALIDATION SPECIALIST
I am a Chemist with eight (8) years of experience in the pharmaceutical industry. I would like to
explore the possibility of joining your crew as a Computer System Validation Specialist. The enclosed
resume will furnish you with information concerning my educational background, pharmaceutical
experience, career objectives, and professional highlights.
I would welcome the opportunity of an interview where we can discuss in detail how my background
and experience can be of assistance to your organization in order to accomplish company goals.
Your consideration of my qualifications for this position will be most appreciated.
Thank you for your interest, attention and forthcoming reply.
Respectfully yours,
Noel Nieves Almodóvar
197 ESTANCIAS DE IMBERY • BARCELONETA, PR 00617
CELULAR 787-***-****
E-MAIL ****.******.*********@*****.***
NOEL NIEVES ALMODOVAR
O B J E C T I V E
Seeking a challenging position that will capitalize and expand the breadth and depth of scientific and technical skills
previously developed through my experiences in which my contributions directly impact and influence business results.
BACKGROUND SUMMARY
Over eight year experience working in the Pharmaceutical industry with state of the arts technologies.
Knowledge of the principles of validation and qualification.
In depth knowledge of the drug development process.
Maintain and constantly develop appropriate knowledge in scientific disciplines through attendance at scientific
meetings, seminars and workshops. Being the most recent an Intensive Program in Biotechnology.
Proficient with computers, laboratory information management system, laboratory data acquisitions systems, and
software and their application to scientific instrumentation required for analysis and communication of results. Hands
on experienced with computer applications such as: Labware LIMS, Empower, Atlas, ChemStore, PeakPro, Trackwise,
AS400, Windows Platforms, Microsoft Office Suites, Calendar, and Web Browsing.
Technical and theoretical expertise and experience with modern analytical techniques and instrumentations such as:
HPLC, GC, Karl Fischer, TOC, pH Meters, Conductivity, UV-Visible, FT-IR, Raman, Atomic Absorption Spectrometer;
Potentiometric Titrations, Particle Size, Klett Summerson Colorimeter, and Polarimeter Auto Pol IV.
Acquaintance of cGMP Guidelines and Regulations, cGLP, 21 CFR Part 11, 210, 211, Change Control, CAPA,
Computer System Validation, Computer System Administration Policies, Analytical Method Validation, and LIMS
Fundamentals.
Technical writing skills, fast-learner, self-motivated, self-taught, organized, leadership, outstandingly detail oriented,
teamwork, bilingual (Spanish and English).
E D U C A T I O N
Dec 1999 University of Puerto Rico Mayagüez, PR
Bachelor of Science in Chemistry.
Aug 2006 Advanced Professional Development Center Aguadilla, PR
(APDC)
Certificate of 9 Days Intensive Biotechnology Industry Training Program Workshop.
W O R K E X P E R I E N C E
Aug 2006–Present VALcoa, Inc. San Juan, PR
@ APP Pharmaceuticals, LLC (Barceloneta, PR)
Validation Specialist
Agilent ChemStation with ChemStore Chromatography Data System (CDS)
Development and execution of System Life Cycle Deliverables (VP, URS, FRS, DQ, IQ, OQ, PQ, TM, SR, among
others). Generate SOP’s: ChemStore (CDS) Operational, Backup and Restore, Disaster Recovery, Security and
Administration.
@ Wyeth Pharmaceuticals (Guayama, PR)
Computer System Validation Specialist
LabWare LIMS v5.02 Implementation
LIMS Master Data (MD) is database static data that is used to define the characteristics, data requirements, and
workflow for dynamic LIMS data. Examples include: Analysis Methods, Laboratory Locations, Product Names,
Specifications, Standard and Reagents, Raw Materials, Stability Protocols, Instruments, among others.
Collection, development, loading and testing/verification of MD for 4 main products including their Product
Specification, Analyses (chem. & microbiology), Instruments, Raw Materials, Standard and Reagents.
Working in close collaboration with the user community representative to assure effective and accurate development
of MD.
Create / Execute Test Scripts. Review the results of testing, and generate MD Summary Reports.
Perform migration/transfer of MD codes between environments (DEV, QA, and PROD).
Data Pack collection of paper and electronic files associated with a MD record containing Source Documents from
which MD can be extracted such as Monographs, Analytical Methods, Testing Standards, Laboratory Notebooks,
SOP’s, Certificates of Analysis, and Pharmacopoeias; LIMS Master Data Routing and Object Move Form, and
Master Data Comment Form used to capture corrections, modifications and deviations.
Verified the accuracy of Master Data by testing (examples include logging samples and entering results to test an
algorithm) in the QA environment. This involves generating test dynamic data that can be used to test static data
that has been loaded.
@ Mayne Pharma (Aguadilla, PR)
Validation Specialist
Thermo “Atlas” Chromatography Data System (CDS)
Coordinate and Lead Project meetings with Site Management and cross-functional groups.
Development and execution of System Life Cycle Deliverables (VP, URS, FRS, DS, IQ, OQ, PQ, TM, SR, among
others). Generate SOP’s: Atlas (CDS) Operational, Backup and Restore, Disaster Recovery, Security and
Administration.
NOEL NIEVES • 787-***-****
Mar 2001–Jun 2006 Bristol Myers Squibb Barceloneta, PR
Chem Lab Analyst (Finished Product & A nalytical Technical Services)
Accelerated Assay Robustness Remediation Project for Barceloneta site.
Exposure to Senior Management while gaining a heightened awareness of the importance of cross-functional
groups to achieve business results.
Experience with aspects of analytical method validation in the pharmaceutical industry concurrently with ICH, FDA
and USP guidelines.
Write, Review, and Execute various protocols and reports for analytical methodologies validation.
Ability to develop and troubleshoot experimental protocols, and recognize when additional consultation is needed to
interpret results.
Driven performer to accomplish tight time lines.
21 CFR part 11 ERS Non Chromatography Remediation Project for the UV2401, AA700, DSC821 and Avatar FTIR.
Review / Execution of protocols for Computer system validation in accordance with 21 CFR part 11 requirements.
Influenced outside vendor to ensure that the high level service required by the organization were met.
Quickly and effectively adapting to new situations and technologies.
Finished Product Lab
Testing of finished Cephalosporin’s and Penicillin’s products. (Bulk, Tabs, Caps, Oral and Parenteral)
Review of chemical analysis for release testing.
Effective training of new and experienced Analysts with frequent feedback and coaching on ways to improve
performance.
Instrument troubleshooting with corrective actions in ways that reduce maintenance cost.
Shift Lab Analyst (In-Process Lab)
Exposed to all related instrumentation and testing required for support manufacturing continuous operation at the
Non Lactam Bulk Plant in a multi-product/processes with a fast pace environment.
Assistance in the Tech-Transfer of Nefazodone for Brischem Plant and lab support to BDPR operation Processes.
Performed In-Process testing to support BDPR operation Processes for Ceftazidime and Cefepime.
PASSPORT MEM B E R S H I P A W A R D S
• •
United Stated of America Passport, since 2005
Spot Award Bristol Myers Squibb Co., Barceloneta, PR – 2003
Commonwealth of Puerto Rico Licensed Chemist, since 2002.
PR-Alliance for Minority Participation Excellence Award (Cash Award) – 1998 & 1999.
33rd ACS-Junior Technical Meeting & 18th Puerto Rico Interdisciplinary Scientific Meeting, Bayamon, PR – 1998.
R E F E R E N C E S
References provided from college and employers upon request.
NOEL NIEVES • 787-***-****
Contact this candidate