SUMMARY:

• Over 7 (Seven) years of experience in Pharmaceutical, Biotech and Drug Manufacturing Industries focusing on Computer System Validation, Process Validation, Instrument Qualifications and Software Quality Assurance.
• Hands on experience in developing and documenting Validation Plan, Validation Summary Report (VSR), Requirement Traceability Matrix (RTM) and Standard Operating Procedures (SOPs)
• Experience in developing Validation protocols, Executing tests and preparing Summary Reports for IQ, OQ and PQ for validations in various pharmaceutical companies
• In depth knowledge of FDA regulations like 21 CFR Part 11, 21 CFR Part 820, 210,211 and other SOX, GxP (GMP, GCP, GLP, GDP) regulations and GAMP5 guidelines.
• Experience in validating a wide variety of applications like LIMS, Service Now, and Track wise.
• Experience in writing Risk Analysis, Gap Analysis, and CAPA documents
• Developed comprehensive Test Summary Report and Test Cases
• Hands - on experience in using tools like HP-QC/ALM.
• Have good knowledge in SQL queries.
• In depth knowledge of Software Testing Methods.
• Good knowledge on Change Management System.
• Have been exposed to different phases of SDLC methodology
• Extensive Experience in Enterprise Document Management System (EDMS) with automated systems such as Documentum, Veeva and Master control.
• Extensive Experience in working with MS Visio, PowerPoint, Word, Access and Excel.
• Excellent Coordination skills, Communication skills and strong Technical Writing skills and a good team player.
• Proficient in learning new technologies and quick at adapting to new environment.
• Able to accomplish tasks without supervision.

TECHNICAL SKILLS:

Validation: FDA regulations, 21 CFR part 11, GXP (GDP, cGMP, GCP, GLP) SOPs, GAMP, GAP analysis, audit trials, summary reports.

Methodologies: Agile, Waterfall and V-model

Applications: LIMS, HP-QC, Track Wise, Documentum, Master control, (BMC Remedy 8.1) PROMISE, Service Now, Veeva

OS and Applications: Windows (XP/2007/2010), Unix, MS Word, MS excel, MS power point, MS Visio, MS Access

Technical Writing: Validation Master Plan, Functional Specification, User Requirement Specification, Test Summaries, Requirement Traceability Matrix(RTM), Release to Production memo.

Analytical Instruments: HPLC, UV-VIS Spectroscopy, IR Spectroscopy, Autoclave

PROFESSIONAL EXPERIENCE:

Confidential, Ann Arbor, MI

Senior Validation Engineer/Engineer - II

• Support production engineering change orders supporting FDA remediation activities for various platforms including: Heart Lung Machine, Machine Shop, and Incoming Quality Inspection.
• Developed project plans and strategy supporting design transfer activities from the development phase to release into manufacturing. Provide daily reports, metrics and project status to management utilizing Microsoft Project, Concerto and burn down charts for Production and Process Controls Remediation.
• Support Design Transfer activities including: Technical Reviews, Gap Assessments, Effectivity Forms, Pilot Reports, Control Plans, Risk Reviews, Supplier Acceptance Forms, Validation Trace Matrices.
• Responsible for product design reviews and transfer process. Drove supplier development by assisting them in developing problem solving control tools such as process mapping, FMEAs, Process Capability studies and Gage R&Rs.
• Independent Reviewer and author for design output technical reviews including work products such as: manufacturing work instructions, quality inspection procedures, part inspection plans, drawings, design specifications, device history records, pFMEAs, risk control option analysis, and process validation assessment matrices.
• Worked with IQA department to update the inspection plans on various components, including First Article Inspections, identified and implemented internal controls to further downstream to detect failures in components. Documented and reviewed these determination of controls to show the compliance to FDA purchase controls regulations.
• Worked on new production chemistry lab launching project. Helped the client in identifying and acquiring new equipment for the lab. Worked in the capacity of validation engineer to qualify the new equipment to bring them under equipment management program.
• Worked in the capacity of SME for P&PC group to assess the remediated products per the New Quality system documentation to certify the current inventory levels and release the parts and components as needed for the production use.
• Worked on a label remediation project. Identified and updated labels per new regulations, design input requirements. Worked with various suppliers and processed label material, color, ink changes within the quality system.
• Worked as Design Quality Validation Engineer for various design changes and production process changes following design control procedures for proper development and control of design plan, design documents and specifications, protocols, V&V as necessary.

Confidential, Ann Arbor, MI

Validation Engineer/Engineer - II

• Participated in remediation plans per DCP, support Test Method Validations and Process Validations activities during Quality System Remediation. Created and reviewed PFMEA, IQ/OQ/PQ/PPQ protocols and reports, analyzed test results, communicated findings and got approvals across all functional teams involved. Assist in developing and execution of test method validation (TMV). Assist in execution of Gage R&R study to determine part variations.
• Served as a core validation team member for product and process development on Manufacturing, Assembly lines for HLM (Heart Lung Machines) for remediation project. Designed, procured and fabricated tooling and fixtures.
• Created and executed FADAL CNC Machine validations, Test Method validations using various measurement equipment, Manual Assembly lines and developed various Engineering and Lab Studies to support the validations.
• Created and updated MWIs, DHRs and BOMs as part of remediation project, performed Test Method Validations and Process Validations activities for OEM and In-Process products. Conducted DOE for process range studies, qualification and validation of specification changes due to remediation plan.
• Created and reviewed PFMEA, Other risk documents, IQ/OQ/PQ/PPQ/TMV protocols and reports, analyzed test results, communicated findings and got approvals across all functional teams involved. Leveraged various existing TMVs and conducted Engineering studies to accommodate the new inspection methods.
• Consulted with various vendors and suppliers in the supplier remediation project. Identified the requirements, and documentation activities such as APQP, FAI-Ds, DOCs as well. Engaged with suppliers and client QMS in successfully implementing the changes from suppliers to client QMS.
• Provided onsite engineering support while ensuring GMP documentation and protocols are in place. Supervise floor operators and technician on maintenance of business and various qualification projects.
• Performed Test Method Validations. Performed GAP Analysis of existing RM Plans and suggested Remediation activities. Developed Standard Operating Procedures (SOPs). Authored Test Protocols and performed Test Method Validations. Validated Test Fixtures, Test Assemblies and Gauges.

Confidential, Kalamazoo, MI

Manufacturing Quality Engineer

• Core member of the validation team for product and process and manufacturing procedures. Wrote and implemented equipment/process qualifications, validations and engineering reports. Conducted DOE for products and processes, launched and completed IQ/OQ/PQ for validation (Crimping Process Validation). Authored, reviewed, and executed PFMECA, IQ, OQ, PQ, Summary Reports, and rewrote SOPs incorporating visual aids.
• Worked in PSP (Patient Specific Products) business unit, to increase the production efficiency using just in time production technique. Conducted time studies on operators to understand the lead and lag time activities between work stations and updated work instructions to increase the work order processing times and efficiency.
• Performed equipment validations of CNC Turn Center SWISS machines including software validations, and implemented new packaging process validation, Chemical Process equipment validation.
• Researched, tested and implemented, improved manufacturing processes. Performed product development, scheduling of manufacturing and DVT (development verification testing) such as package validation, Machinery validation.
• Conducted DOE for process range studies, qualification and validation of specification changes due to non-conformances, process maintenance and improvements using statistical software's such as Minitab and Change-Point Analyzer. Created and updated Change Request's for Installation Qualification's, Standards Operating Procedure's, Gage R&R's etc.
• Experienced with sampling plan sizes and different statistical tests. Experienced in process mapping and process characterization studies.
• Participated design, process Risk Analysis, Engineering and design Change Control and Engineering Change Control meetings. Processed numerous change orders coming from Production Supervisors to production floor workers dealing various levels of errors in the machining and assembly. Interfaced with Engineering and Operations to ensure product changes are in accordance with approved data.
• Worked with Engineering to establish and maintain part and assembly specifications. Initiated CAPAs and ensured timely completion of CAPAs. Performed TMV's for Visual Inspection dimensional measurements. Created test methods and fixtures for destructive strength tests.
• Successfully resolved CAPA on label misprinting problem and Interference Assembly problem of product. Performed root cause analysis, implemented immediate containment and correction actions to reduce the impact and implemented corrective and preventive actions to eliminate the issue. Participated in VoE process as well to determine the accuracy of the solutions.
• Tasked with closing out multiple Non - conformance issues, by investigating root causes, and implemented corrections for NCs. Implemented various corrections to NCs and helped in clearing the products from MRB through TA, DCR processes, Responsible for hands-on and project management of corrective actions for NC’s.
• Hands on experience with inspections using custom fixtures, equipment and created new Inspection sheets for various machine shop products. Performed test method validations on height gages, calipers, thread gages, micrometers.

Confidential, New Jersey

CLEANING VALIDATION CONSULTANT

• Skilled and knowledgeable in medical device manufacturing and product processing
• Prepared and Reviewed SOPs for various process steps
• Responsible for the development and implementation of the Site Validation Master Plan
• Generated Cleaning Development and Cleaning Validation study protocols for equipment and processes as per FDA regulations and company standards for all Ethicon sites
• Involved with execution of cleaning development studies and generated summary reports at the end of validation
• Supported laboratory based cleaning validation studies, including but not limited to method validations and coupon studies
• Assisted in Root Cause Investigation and developed resolutions for deviations encountered during development activities
• Trained manufacturing and operation staff on equipment protocols and cleaning procedures

Confidential

Validation Engineer

• Analyzed and reviewed Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols.
• Responsible for assisting in the implementation of software systems in compliance with regulatory requirements as they pertain to 21 CFR Part 11 and GAMP 5.0 standards.
• Authored, reviewed and approved CSV deliverables (validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and validation Summary Report).
• Support Quality System development and improvement with respect to GMP systems and development team compliance to ISO and FDA regulations.
• Facilitate the implementation of a Quality System which complies with ISO 13485, FDA 21 CFR Part 820, and other international regulatory guidelines.
• Assured that all system's validation documentation such as IQ's, OQ's, and PQ's are in compliance with cGMP's (21 CFR Part 210/211).
• Developed and executed the IQ, OQ, PQ for Waters Empower Software, CDMS & CTMS applications
• Well demonstrated expertise in implementing prospective and retrospective validation systems in compliance with 21 CFR11 and 21 CFR 820.
• Ensured that the documentation adhered to the FDA Regulatory Requirements.
• Involved in validation of EDMS (Electronic document management system) which is used to track, manage and store documents in compliance with cGMP, FDA norms and 21CFRpart11.
• Excellent working knowledge in Track wise (CAPA), Information Request Management System (IRMS), Electronic Document Management System (EDMS), Inventory management system (IMS)
• Validated systems used for CGMP and Non-CGMP purpose.