Validation Engineer, IQ/OQ/PQ, SOP, Change Control, CAPA

Note:

I wanted to address this letter to you by name but I was unable to obtain it. I am very interested in this position.

After

some consideration, having completed a very important life and professional

cycle in my native Puerto Rico, me and my family have decided to move to the US

determined to explore opportunities in such competitive market.

I

am an engineer with extensive experience in Quality by Design (QbD), Process

Analytical Technologies (PAT), Critical Quality Attributes determination and

monitoring, and Validation of Process, Equipment, Methods, Instruments,

Facilities and Utilities.

In

essence, I'm seeking for a good challenge in a competitive organization where my

abilities, experience, and engineering skills could fit and add immediate value

for the benefit of all the parties involved.

Based

on my Computer Engineering college degree, as my professional platform, I've

been a hands on professional, a good self-motivated learner, always focused,

with good energy and initiative to approach opportunities and select the

pathway that more sense and value bring to the table.

As per your instructions, please

find below my resume hoping you find in my profile and background something

that you like and need, so we move on and tackle together challenges in your

portfolio and the new ones that we could make possible for the coming years.

I

can be reach via my cellphone 787-***-**** or by email at

*******@*******.***.

Thank

you for your time and consideration.

Sincerely,

Reinaldo Vázquez

PRPROFESSIONAL PROFILE

An

engineer with extensive experience in several areas of Validation: Equipment,

Facilities, Utilities, Instruments, and Methods. Passionate with teamwork, technical

challenges, and high quality deliverables.

Hands-on experience in the Investigation of Manufacturing events, Process

Development, qualification of chemometric models, Process Analytical

Technology (PAT) methods and instruments.

Fluent in both, English and Spanish languages.

prPProfessional experience

Conde InduServices

2014

Principal Validation Eng. (Zimmer– Ponce, PR)

Performed Audit to the Continuous Process Monitoring

(CPM) Program. Recommend new

technologies for CPM program. Support Zimmer’s response to FDA Audit.

Janssen Pharmaceuticals (Gurabo,

PR) 2012

- 2013

QA Manager, Design to Value (DtV))

Procure Global implementation of Design to Value (DtV

- Janssen way for Quality by Design). Ensure Global Standards were aligned with DtV initiative.

Represent Quality on all DtV teams.

Product Quality SME for DtV. Support

Continuous Manufacturing Real Time Release project.

Conde InduServices

2011 - 2012

Sr. QbD-PAT Validation Eng. (Amgen – Juncos, PR)

Generate and execute the qualification activities for

an Ultraviolet (UV) sensor used as a PAT tool to quantify protein loss on an

ultra-filtration system. Develop SOP

for its use and generate instructions for calibration. Support Method

Development and Validation activities.

Design construction aids to optimize sensor installation. Responsible for the generation of User

Requirement Specifications for NIR instrument for blend monitoring and

tablets analysis. Support the

development of SOP for PAT Implementation.

Pfizer Pharmaceuticals (Wyeth

Legacy -Guayama, PR)

2003 - 2011

Sr. PAT Validation Specialist I

Active role in the design, documentation, implementation,

validation and training of a Real Time Release platform using PAT tools

throughout the complete manufacturing process (Incoming Materials,

Mixing/Blending, Roller Compaction, Compression, etc.). Key member in the development and creation

of a modern industrial concept of professionals working in a QbD-PAT

environment. Responsible for the

generation and execution of qualification activities of Process Analytical

Technologies (PAT) tools and instruments.

Perform feasibilities studies and Design of Experiments (DoE) to

develop and validate chemometric models and methods. Design engineering controls, construction,

optimization and implementation for PAT instrumentation in the cGMP

environment.

Investigate deviations, out of specifications, and events

on the manufacturing area. Perform

root cause analyses to determine CAPA activities.

Washington Group International

(formerly known as Raytheon Engineers) 1994 - 2003

Validation Engineer

Perform validation projects at several pharmaceuticals in Puerto

Rico (Merck, Abbot, Pharmacia) in different areas such as: Facilities, Process

Equipment, Instrumentation and Controls, Utilities, and Computer Validation. Provided guidance on generation and

maintenance of Process and Instrumentation Diagrams (P&IDs).

EDEDUCATION

University of Puerto Rico, Recinto

Universitario de Mayaguez (RUM)

Bachelor

in Computer’s Engineering

n Member of the Computer Engineering Student

Association (Treasurer)

Certitifications

Process

Analytical Technology (PAT) Certification

Intermediate

Chemometrics

ACACOMPLISHMENTS

Key member of the leading team that received the first FDA

approval for Real Time Release testing (RTRt) application for a controlled

release product.

Member of the first group of personnel from Wyeth selected to

close the gap between Research and Development (R & D) and Manufacturing.

Reduced variability in particle size measurements by providing

engineering controls.

Employee of the year for Raytheon Engineers.

SKSKILLS/TRAININGS

Quality by Design (QbD) and Process Analytical Technology (PAT)

Implementation in the cGMP environment

a. Feasibility Studies on

different technologies (NIR, LIF, Laser Diffraction)

b. Design of Experiments

c. Method Validation

d. Chemometric Modeling and

Data Analysis (Unscrambler, Excel and Minitab)

e. Instrument Troubleshooting

and Qualification

The 7 Habits of Highly Effective People

Minitab Training with Basic Statistical Training

Problem Solving and Making Decisions, Kepner-Tregoe

PAT, QbD, and Pharmaceutical Manufacturing Processes Trainings

by Dr. Carlos Conde

Certified Trainer (Train the Trainer)

Computer System Validation Technical Training

Microsoft Office (Word, Excel, PowerPoint)

Bilingual (English / Spanish)

Contact this candidate