SUMMARY:

Six years of extensive experience as a Process Validation Engineer

Pharmaceutical with far reaching capability and cleaning
validation.
Strong understanding of 21 CFR Part 11 drug cGMP requirements
including electronic records, electronic signatures, system validation
strategies and documentation.
Good knowledge of FDA and ISO requirement relating to validation
program and documentation practices in accordance with cGMP
guidelines including Documentation of all the individual steps of
Validation Life Cycle of processes.
Extensive experience in authoring and executing all system
qualification documentation including Validation/Test plan, user and
Functional
Requirements
Specification,
Test
cases/scripts,
Requirements Traceability Matrix (RTM) for IQ/OQ/PQ protocols and
summary reports with exposure to full Validation Life Cycle.
Troubleshooting issues related to the process development
from DOEs to the operational stage.
Good understanding of automated process control systems, clean room
and classified area requirements for Aseptic Environment.
Strong involvement in usage of Change Management/Control and
Corrective Action and Preventive Action (CAPA) methodology
Proficient in Generating, assessing and insisting the Validation related
Documentation. Working learning in temperature mapping using the
KAYE Validator structure.
Experience in Process Qualification and Requalification for aseptically
produced bio-pharmaceutical drug product.
Knowledge of Clean-in-Place, Sterilization-in-Place (SIP), Drying-inPlace (DIP).
Possesses excellent written and verbal communication skills with
strong abilities in requirement capture, analysis, design and
development in large application development projects
TECHNICAL SKILLS:

Equipment
Validation

Autoclaves, HPLC, UV Spectrophotometers, GC, pH

Meters, TFF skid, CIP Skid, Incubators, Freezers, Spray
Dryers, Isolators and Bioreactors

Cleaning Validation
Process Validation
Testing tools
Application
Software

QTP and Quality Center

MS - Office, MS share point, Documentum Minitab

PROFESSIONAL EXPERIENCE

BD Pharma, NJ

Jan.2014-

Aug.2015
Validation Engineer
Responsibilities
Prepares process validation and process verification protocols for

drug products to be validated.

Executes process validation on

the

compounding

floor. Prepares process validation and process verification

reports

after drug product validation is done.

Prepares flow diagram, charts and collects pertinent data and tests
results

from

QC

and

Microbiology

departments

to

complete

the validation reports Supports the conversion of small scale into

commercially viable large scale operations.

Assesses processes for their relevance and adequacy of engineering
equipment. Reviews existing data to see if more researches and

information needed to be collated.

Ensures that the process works at the optimum level to the right
rate

and

quality

output

to

meet

the

supply

needs. Takes

observations and measurements directly as well as collate and

interpret data for the other operating and technical staff involve
reviewed multiple protocols, iq,oq,pq sops deviations and document

changes through the change control process

Authored sampling plan where when and how the samples are taken
Proposed time frame and acceptance criteria within process controls
Authored critical processing steps to be monitored during validation
Authored validation summary report containing all the information
regarding batch analytical data,batch production records and report

on unusual findings conlusions

Executed additional testing with proposed acceptance criteria and
analytical validation clearly define procedures to control changes
proposed in production process according to GMP

Achieved sterilization by different methods depending upon material,

the aim and the possibility of residues of used sterilization agent and
validation of sterilization of all components such as Ph shifting, TOC
Viscosity and conductivity of solution to be filtered
Authored validation protocol considering transport to microbiological
laboratory, sampling sites and time of sampling, test methods
,incubation, limits and evaluation once the process has been clearly
defined
reviewed the equipment adjusment calibration and maintananance
if the sterilization process is automated with softwre reviewd validation
protocol,softwarer requirement document ,validatio acctivities ,cahnge
controls and vallidation results.control confirme taht the software is
validated
utilize six xigma ans spc tools to analyze data make acceptance
intervals and improve process capability
exposure to spin coating, mask aligning and chemical vapour
deposition
Reviewed and revised process failure mode effect analysis (PFMEA)
ensured validation of documenation fo complianve of GxP

Chantilly Biopharma Chantilly, VA

Sept.2015-

PresentCleaning Validation Engineer

Responsibilities
Authored
cleaning
approval
Protocols
for
Pharmaceutical
Manufacturing supplies
guaranteeing the consistence of
acceptance archives with cGMP and 21 CFR Part11.
Performed cleaning approval of a wide range of assembling supplies
like Twin shell Blenders, Sieving Machines, Tablet press and Fluid
bed dryers and so forth.
Developed testing procedures and compelling methods to gather
tests to enhance existing convention and gathered the inspecting
areas for swabbing from Environmental checking conventions.
Was in charge of gathering wash and swab tests aseptically from
hardware and vessels that turned out from assembling process.
Calculated the Acceptance criteria to decide the worthy remaining
cutoff points of the Active Pharmaceutical Ingredients (API) and
Detergent. Involved in collecting the samples and submit them to
QC.
Assisted in creating and approving Analytical strategies used to
dissect the swab tests.
Prepared System Suitability Solutions to investigate the swab tests
and wash from the assembling types of gear.
Designed, performed Visual Inspection Test technique to decide the
acknowledgment criteria of cleaning acceptance convention of
assembling hardware.

Reviewed and reported Training records, Batch records, Supporting

Documents, Equipment log books and SOPs
Reviewed and upgraded the Cleaning Validation Master Plan (VMP)
and performed cleaning acceptance exercises.
Cleaning Validation Research: Developed cleaning approval
systematic techniques, performed linearity, specificity, exactness,
and toughness tests.
Performed Ongoing Verification of the cleaning procedure.
Reviewed and archived cluster records with more prominent
consideration on major and minor points of interest with least
supervision.
Part of the deviation reaction group, which is in charge of producing
deviation reaction conventions to counter unanticipated deviations
and disparities and executed CAPA and NCR
Responsible for creating Cleaning check study between time reports
and synopsis endless supply of a clump.
Tested and checked the Reliability, Reproducibility and Cleaning
Efficiency.
Worked intimately with topic specialists (SME) in creating
modifications for the cleaning confirmation study convention and
cycle advancement convention for approval.
Merck & Co., NJ
June 2010Dec.2011
Validation Engineer
Responsibilities:

Involved in protocol generation, execution and summary of various

pieces of new and relocated equipment (autoclaves, depyrogenation
oven, controlled temperature units, etc.), and the compliance review
and coordination of vendor protocols for bench-top equipment (HPLCs,
DNA Synthesizers, etc.).
Developed SOPs and IQs, OQs, PQs for validating HPLC system
specifically for the Electronic Records and Signatures
Reviewed Autoclave validation by developing validation cycles and load
configurations.
Translated business specifications into User Documentation
Involved in Validation (IQ/OQ) of instruments and qualification of
automated control system.
Worked with QA/Compliance to track and coordinate any validation
change control and/or corrective actions.
Assessment for compliance with 21 CFR Part 11 (Electronic Records and
Signatures), 21 CFR Part 211 (cGMP for Pharmaceuticals).