SUMMARY

• Over 7+ years of experience as Cleaning Validation Consultant, Validation Engineer, Equipment Validation Engineer / Technical Writer in Pharmaceutical, Healthcare, and Medical Device Industry • Hands - on experience on analytical Lab instrument, Equipment, and software such as HPLC-Empower software, GC, Spectrophotometers, FTIR, UV-Vis, and others. I.e., the Installation Qualification (IQ) and Operational Qualification (OQ) through the Performance Qualification (PQ) phases.
• Experience in areas such as Quality Assurance, Quality Systems, Quality Control, Validation, and Manufacturing. • Hands on experience of using Kaye Validator 2000 for performing SIP penetration studies • Corrective Action and Preventive Action (CAPA) and system deviations - identification, tracking, and resolution.
• Possesses excellent written and verbal communication skills with strong abilities in requirement capture, analysis, design and development in large application development projects • Ability to communicate effectively, enthusiastic, self-motivated, and highly organized. • Extensive Experience in reviewing Standard Operating Procedures (SOP), Validation Master Plan (VMP) and Validation Summary Reports (VSP)
• Industrial experience and Good understanding of FDA's 21 CFR Parts 11, 50, 56, 58, 210, 211, 312, 314 and 820; ICH - GCP Guidelines and ISO 13485 • Adapt knowledge about analytical laboratory procedures, experience in operating troubleshooting and supporting analytical equipment like HPLC, GC, UV-VIS Spectrometers, Spectrophotometer, Autoclaves, pH meters and incubators
• Expertise in Corrective and Preventive action (CAPA). • Experienced in managing schedules, deadlines, and resources using MS Project considering the Triple Constraint and creating Work Breakdown Structure (WBS) and MS PowerPoint presentations for management review Willing to relocate: Anywhere Authorized to work in the US for any employer

TECHNICAL SKILLS

• CAPA/Deviations
• OOS Investigations
• Validation Analytical Software LIMS
• AERS
• SAS-JMP Quick Test Professional
• Load Runner
• Quality Center HPLC
• GC
• FTIR
• UV-Vis spectrophotometer
• Tablet Punching Machine
• Franz cell diffusion apparatus
• Capsule Filling Machine
• Cleaning validation
• Process and equipment validation
• CIP
• GC
• FTIR, UV-Vis spectrophotometer
• Tablet Punching Machine
• Execution of IQ/OQ/PQ EDMS HPLC
• Incubators
• Spectrophotometer
• Validation Protocols
• Reports Databases

PROFESSIONAL EXPERIENCE

Sr. Validation Engineer

Confidential, Fort Washington, PA

Responsibilities:

• Preparation of cleaning assessment Documents, Chemical Laboratory Tests and Reports for the optimization of the cleaning processes for Manufacturing and Packaging Operations. • Developed Cleaning Validation Master Plan for Biotechnology and Aseptic Fill and Finished Operations according to the client policies and Quality Standards.
• Prepared and executed cleaning validation Protocols, wrote Final Summary Reports for Manufacturing and Packaging Areas • Conducted GAP Analysis to follow 21 CFR Part 11 • Developed Product Contact and Equipment Surface Area for Manufacturing, Packaging and Filling equipment trains for Cleaning Validation Program in Chemical, Parenterals and Semisolid Operations.
• Provide guidance on best practices to follow guidelines set by the FDA for electronic systems as defined in 21 CFR Part 11 • Ensure manufacturing biotechnology equipment's qualification standards, process, and systems accordingly with federal and state regulations toward validation cGMPs, including document control, validation Work in CIP/COP and manual cleaning validation activities (Manual Washer and Ultrasonic)
• Executions of Protocol run for IQ, OQ, and PQ using the manufacturing equipment. • Developed Cleaning Validation Summary Reports Closed cleaning validation packages as a part of the remediation plan. • Responsible for activities associated with the steam sterilization validation of a wide variety of biopharmaceutical manufacturing equipment and autoclaves.
• Performed temperature mapping of controlled temperature units including freezers, refrigerators, and incubators a necessity.
• Experience in placing and removing biological indicators required • Audited Process Cleaning validation, Utilities, Support System, and Laboratory Equipment Qualification validation packages according to company policies and updated requirement
• Prepared list of documents required for the cleaning validation system based on GAMP5 • Recommended validation Deliverables and level of testing to be conducted

Validation Engineer

Confidential, Suffern, NY

Responsibilities:

• Write cleaning validation protocols for new product transfers • Execute cleaning validation protocols for tablet and capsules manufacturing areas • Working with the Validation Manager, collect samples and oversee all testing data from Process/Packaging/ Cleaning Validation to ensure data is accurate and within acceptance criteria. • Submitting cleaning samples to Biochemistry/Microbiology labs
• Performing cleaning recipes on different liters of bioreactors using clean in place skids • Monitoring and documenting data while the cleaning process is in. • Author, execute and perform sampling for Process Validation, IOQ, and Packaging Qualification and Cleaning Validation protocols.
• Supporting manufacturing and production area by reducing micro contamination, cleaning validation and improving any process or SOP's for the control of microorganism in the plant. • Developed cleaning validation protocol and final report template, Dirty/Clean Idle Time expiration report template
• Performed Cleaning Verification studies and prepared interim reports to release equipment and product. • Executed, and close out SIP performance qualification (PQ) protocols. Hands on use of the Kaye Validator for performing SIP penetration studies a necessity
• Performed cleaning verification for laboratory equipment - HPLC, GC column as per vendor defined procedures. • Handled Re-evaluation of cleaning of manufacturing and packaging equipment.

Validation Engineer

Confidential, Pennington, NJ

Responsibilities:

• Performed and executed Validation, Qualification and Re-Qualification protocols for the Manufacturing Equipment /Process and aseptic areas.
• Authored validation documents independently such as OQ and final summary report for the qualification of HPLC. • Involved in Operation Qualification using thermocouple calibration and Temperature mapping of equipment like autoclaves, TOC, incubators, freezers, refrigerators, ovens.
• Reviewed and developed validation deliverables- master plan/Summary Report, URS, FRS, Requirement traceability matrix (RTM), IQ, OQ and PQ protocols • Authored validation documents such as IOQ for the qualification of new replacing HPLC columns. • Conducted equipment validation (FAT, SAT, IQ, OQ, PQ) at supplier sites extending through manufacturing transfer
• Executed Operational Qualifications (OQs) to make sure that the columns are capable of consistently operating within established limits and tolerances • Prepared and executed commissioning and qualification documents for utilities and equipment • Hands-on experience in the use of Kaye Validator 2000 for performing temperature mapping of controlled temperature units including freezers, refrigerators, and incubators
• Executed Design Qualifications for analytical lab equipment. Like HPLC, GC and UV Spectrophotometers. • Responsible for inspecting equipment in the regulated pharmaceutical sector in accordance with GXP systems. • Drafted and executed of Analytical testing instruments, equipment and software such as HPLC and the associated software (Empower), HPLC, GC, FTIR, UV-Vis Spectrophotometer. • Ensured complete 21CFR part 11 compliance assessments for manufacturing systems • Root Cause Analysis with Design of Experiments to drive out variation in test equipment.

Validation consultant

Confidential, Field, Illinois, US

Responsibilities:

• Generation and execution of validation protocols and generation of summary reports.
• Involved in commissioning, qualification and validation of laboratories and analytical equipment like HPLC, FTIR, TOC Analyzer, Airborne and Liquid-borne Particle Counters, Microplate Readers, Plate washers, and Spectrophotometers.
• Assisted in developing VP, URS, FS, I/OQ & PQ protocol templates to establish a higher quality standard for qualifying automated process kettles, Girton parts washer/sanitizer.
•  Supported the revalidation and change control programs at pilot plant facility. Conducted Steam-in-place (SIP) studies on portable tanks and Autoclaves
• Assisted with all aspects of Cleaning Validation such as site sanitization programs, site environmental monitoring, program, scientific rationale swab locations, swab qualification, visual inspection qualification, analytical method for detergent, micro method, cleaning procedures and all other documents relevant to the site cleaning validation program.
• Created cleaning cycle development strategies and qualifications for a variety of equipment including process vessels, chromatography skid/column, buffer preparation, glass washers and parts washers.  Analyzing Critical cleaning parameters. • Developed the cleaning method and analyzed the samples for TOC and bioburden.
• Performed the Swab sampling for the Production equipment and instrument for Microbial contamination and residual contamination.
•  Executed cleaning validation and verification protocols.
•  Perform Temperature Mapping/Biological Challenge studies on cGMP Autoclaves.
• Developed Standard Operating Procedures for laboratory equipment based on user requirement and functional requirement specifications.
• Authored and approved IQ, OQ, PQ, FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) for equipment using the production equipment.
•  Used Kaye Validator to perform temperature mapping of controlled temperature units (refrigerator, freezer, walk-in-freezer, autoclaves, incubator, walk-in-incubator and cryo freezer).
• Reviewed SOPs for the Installation Qualification of this equipment and wrote summarized SOPs for the theory of operation as well as the working conditions for them. This was done to help a new operator understand the operations easily. • Wrote and reviewed the system related SOPs to ensure compliance with company's processes, policies, and procedures.
• Involved in the documentation of different stages of validation lifecycle in compliance with 21 CFR Part 11.