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Sr. Validation Scientist

Location:
Humacao, Puerto Rico, 00791
Salary:
80k
Posted:
March 19, 2019

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Resume:

Angela R. Rodriguez Sanchez 787-***-****

Urb. Mansiones del Caribe 225 Calle Agata, Humacao PR 00791 ac8t12@r.postjobfree.com

Summary and Highlights

More than (16) sixteen years of experience within the Pharmaceutical, Healthcare and Bio-Pharmaceutical Industry. Knowledge in solid and semisolid pharmaceutical manufacturing validation. Hands on experience in defining validation for systems and processes with sound knowledge of protocols for equipment and processes. Self-starting oriented towards operational excellence, productivity, quality and innovation. Proven ability to work with people to achieve results, meeting company expectations and goals.

IQ, OQ, PQ, PPQ, SAT, Commissioning and Reports Validation

Change Management, CAPAs, Deviations, Investigations (Trackwise)

Manufacturing and Packaging Process Validation

VP, URS, DS, TM, Technical Assessment

Utilities and Facilities Equipment’s

CSV, SDLC, Infrastructure, IT

Startup Projects, Mini-tab, LIMS, SAP, CMMS

SOPs, Syncade (DCA), eBR, MES (PAS-X)

Product Transfers

Auditing Manufacturing Process

Quality Management Systems

Professional Experience

Sr. Validation Scientist / CSV

Merck & Co., Inc. (MSD Sharp & Dohme) 2017 (Mar) – to present

Contractor (Weil Group Corp.)

Manage validation activities (IQ / OQ / FQ / PQ) of all equipment of the company such as (manufacturing, packaging, laboratory and CSV).

Manage Change Controls (Parent Change and Action items within Trackwise) from open to closed status, process validation, IQ/OQ/PQ projects.

Manages change controls and task activities which may span multiple sites.

Independently manages projects associated with change controls and develops systems in support of new product introductions.

Challenges technical support and production groups to ensure robust changes are implemented

Manage CAPAs, Risk Assessment and qualifications for existing equipment. Provide support to validations for new and existing processes and experimental trials for the manufacturing areas.

Executes validation activities to include Change Control initiation, protocol preparation, scheduling, protocol execution, data review and final report generation. Manage Serialization Packaging development process, including the creation of packaging designs, development and performance testing.

Manage the integration of Computer Workstations into Shop Floor Network, the installation of Cylance protects software and standards for cybersecurity such as (Lace, Disintegrator, Lighthouse, MicroSeq, Titrator, TOC, TPW, TruScan, TVS, VITEK2, IR Raman).

Proficient with all phases of SDLC (System Development Life Cycle) process, Data integrity and validation methodologies.

Manage change proposal for the upgrade of PAS X MES software version (Werum’s) project.

Manage Exceptions/Deviations during final verification testing up to approvals.

Coordinate and provide technical support on new product introduction, product transfer activities, including sampling rational, data gathering and analysis.

Manage multiple projects simultaneously.

Sr. Validation Specialist II

PuraCap Caribe Pharmaceuticals 2016 (Mar) – 2016 (Dec)

Dorado, PR

Creating Validation Master Plans and developing validation specifications for various equipment, process and Tech Transfer activities.

Comprehensive knowledge of production processes, validation strategy, and validation methodologies.

In-depth knowledge of pharmaceutical production processes, risk management, and strategic resource management.

Hands on experience in commercial production environments and computer validation methodologies.

Well versed in mitigation approaches, product launching, and project management Designs and conducts technology transfers and process validation activities for oral solid drug dosages (OSD) products.

Handle the tasks of checking memory performance and testing prototype machines.

Provide engineering support in manufacturing processes as well as perform root cause analysis of existing products.

Perform investigation and analysis of validation outcome and implement effective solutions to solve issues. Handle the tasks of providing training sessions to validation engineers and handle critical systems as required.

Manage commissioning and validation activities (IQ / OQ / FQ / PQ) of all equipment of the company such as (Manufacturing and packaging area, facility, utilities and CSV).

Create and populate a database which contains all manufacturing /packaging equipment information including area of service, individual data, available validation packages and any pending corrective actions.

Responsible to evaluate, prepare and execute documents for process validation protocols, product transfer (IQ / OQ / PQ) and Technical Assessments. Also, review and approve Qualification Documents as part of Engineering Department.

Writes Summary Reports of executed validations, qualifications and other among.

Performs Investigations and writes Deviation Reports following the established timelines.

Provides impact assessments during development of Deviation Investigations, CAPA or NOE’s.

Develops and revises Standard Operating Procedures (SOP’s), PMs, Calibrations and Spare Part List of the validation exercises.

Must be able to manage multiple projects simultaneously.

Sr. Process Validation Scientist

Bristol Myers Squibb, Humacao PR 2014(Mar)-2016(Jan)

Contractor (Spectraforce Technologies Inc., NC)

Comprehensive knowledge of production processes, validation strategy, and validation methodologies.

In-depth knowledge of pharmaceutical production processes, risk management, and strategic resource management. Hands on experience in commercial production environments and process validation methodologies. knowledge in statistics such as Statistical Process Control (SPC), Process Capability Analysis, Regression Analysis and DOE.

Well versed in mitigation approaches, product launching, and project management Designs and conducts technology transfers and process validation activities for oral solid drug dosages (OSD) products.

Prepares documented protocols and reports for validation exercises in compliance with corporate guidelines, procedures, FDA Regulations and industry current practices.

Prepares assessments to support that validated critical process and operational parameters are within qualified parameters for specific oral solid drug dosages (OSD) products. Identify and propose equipment enhancements to support intended process operational ranges.

Develops and executes protocols to conduct process validations, performance qualifications and experimental studies.

Prepares and revises manufacturing instructions as required based on the study performed.

Determines the needs and coordination for Placebo and Experimental (DOE) testing materials for validation and performance qualification studies.

Identifies, plans, and implements quality/productivity initiatives associated to process validation and performance qualification activities based on business needs and priorities.

Sr. Validation Specialist / Reviewer

Novartis Ex-Lax, Humacao and Mylan LLC, Caguas 2012(Aug)-2013(Dec)

Contractor (Business Excellence Consulting)

Responsible for creating Validation Master Plans and developing validation specifications for various equipment and process.

Develops process sampling plans to meet process validation requirements and statistical process monitoring requirements.

Coordinates the execution of validation exercises, ensuring successful and timely completion of validation activities per the established protocol. Designs and conducts process validation activities for oral solid drug dosages (OSD) products.

Complete a Gap Analysis to identify the opportunities to improve and/or amend the activities performed as part of the Qualification Process of the manufacturing plant.

Sr. Validation Specialist II

McNeil Healthcare LLC, Las Piedras (Consent Decree) 2011(Mar)-2012(Aug)

Contractor (Mirus Consulting Group)

Responsible to evaluate, prepare and execute documents for process validation protocols, equipment qualification protocols (IQ / OQ / PQ) and Technical Assessments. Also, review and approve Qualification Documents as part of TS Department.

Coordinates the execution of validation exercises, ensuring successful and timely completion of validation activities per the established protocol.

Validation Consultant

Schering Plough/Merck LPO and Mylan LLC 2010(Mar)-2011(Mar)

Contractor (Mentor Technical Group Corp.)

Responsible of perform and execute Packaging Protocol Process of Clinical Studies for commercial and stability lots. Evaluate, prepare and execute documents for optimizing processes including development plans (Development Plans & Reports) and process validation protocols, equipment qualification protocols (IQ / OQ / PQ) and Technical Assessments.

Development and execution of equipment validation activities IQ/OQ for the Packaging Line (Filler/Capper, Air Jet, Induction Sealer, Retorque, Labeler Machine/Laetus System, Microscan Vision System and Wolke Printer).

Perform equipment Validation activities IQ/OQ/PQ for the Blister Packaging Line equipment (IMA Blister Machine, IMA FLexa Cartoner, Checkweigher Machine and IMA Over wrapper).

Develop and validate (IO/OQ) to Fluid Bed Dryer System and Collette GraL 600L High Shear Mixer/Granulator equipment.

Validation Specialist

Wyeth Consumer Healthcare/Pharma, Guayama PR 2007-2009

AMGEN Manufacturing Limited, Juncos PR

Contractor (Validation & Engineering Group, Inc.)

Development and Execution of Validation equipment IQ/OQ and Commissioning for the different process equipment (Sugar Coating Machine SCADA Systems with Operator Interface Terminal (OIT), Programmable Logic Controller (PLCs), Metal Detectors, Scales, Compress Air, Air Handler Unit, Chilled Water Pump, Technical Report of TC450 Capper Machine and Bottle Unscramble Model S-4.MPB/H-100 and Purified Water to new area).

Responsible to evaluate, prepare and execute documents for process validation protocols, equipment qualification protocols (IQ / OQ / PQ) and Technical Assessments. Also, review and approve Qualification Documents as part of TS Department.

Validation Specialist

GlaxoSmithKline, Cidra PR (Consent Decree) 2006-2007

Contractor (Fluor Daniel Corp.)

Development and Execution Validation exercises IQ/OQ and Commissioning for multiple process different equipment (Portable Tanks, Blender, Roller Compactor, Coaters, Scales, FETTE 3090i and Drum Lifter).

Responsible of perform and manage multiple projects of validation process and equipment qualifications.

Responsible to evaluate, prepare and execute documents for process validation protocols, equipment qualification protocols (IQ / OQ / PQ) and Technical Assessments.

QA Auditor

Watson Pharmaceuticals, Humacao PR 2002-2006

Auditing and Reviews weighing, blending, granulation, packaging, film coating, encapsulation and compression Batch Records for compliance, completeness and accuracy.

Evaluated quality of assigned projects and products that will be delivered.

Communicated major status of projects QA personnel and customer concerns to the QA Manger in a timely manner.

Auditing additional task related to Validation Process, Batch Records/Packaging Orders, Incident Deviation, Analytical Reports/Test Method and Raw Materials.

Delivered weekly status reports and applied excellent escalation skills.

Recommended developed and reviewed QA standards policies and procedures for all functions involved with or related to the quality and testing in accordance with company standards.

Education

University of Polytechnic, PR

Master’s Degree in Manufacturing Competitiveness 2017-present

University of Turabo in Gurabo, PR

Bachelor’s in Computer System Technology 1997-2002

Associate in Computer Sciences 1997-2000



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