SUMMARY

• Over eleven years of combined experience in manufacturing engineering, lean six sigma methodologies and quality engineering within pharmaceuticals, biomedical and medical device industry
• Knowledge of GxP, cGMP Standards, 21 CFR, Part 11, Part 211 Compliance, ISO 13485, a strong base in designing strategy, executing business development initiatives and raising operational efficiency.
• Influential leader in implementing lean manufacturing methodologies for GxP purpose process/equipment for the site.
• Supported hosting, fact - findings and response for various regulatory agencies (FDA, EPA, BSI, TGA, and AATB) and sponsor/client audit.
• Involved in developing and implementation of critical procedures with respect to manufacturing. Electronic Batch Record, Data Integrity, Site Calibration Program, Building Management System (BMS), Preventive Maintenance Schedule, Engineering Document Control Procedure & Operation and Maintenance of various other utilities.
• Knowledge in Facility and Utilities Validations, Validation Life Cycle (VLC), SDLC (Software Development Life Cycle)
• Efficient in implementing QA auditing and methodologies and technical writing
• Deep understanding of GxPs (Good “x” Practices) like GCP, GLP, GMP and GAMP and their proper implementation.
• Excellent skills in technical writing for engineering deliverables and procedural development for site/company.
• Experience in Biotechnology, Pharmaceutical and Medical Device Industry and strong knowledge of compliances in these industries.
• Dynamic person with drive and perseverance, innovative, creative and enjoys challenges. Positive attitude and desire to complete tasks.
• Good communication skills along with analytical and problem solving skills.

TECHNICAL SKILLS

• Product Development
• Cost saving
• R&D
• QE
• QA
• FDA
• ISO pFMEA
• Lean Manufacturing
• Project Manufacturing
• Technology Transfer
• ECO
• DCO
• CCR
• CAPA
• Process Development
• Aseptic Processing
• EHS Auditor
• Cross functional.
• Microsoft Windows 95 98 2000 XP
• MS Power Point
• Internet Explorer
• Microsoft Project
• Microsoft Excel
• Visio
• Track Wise
• Agile.

PROFESSIONAL EXPERIENCE

Confidential, Plainsboro, N.J.

Validation Engineer

Responsibilities:

• Create, execute, and obtain approval for qualification and validation protocols and reports.
• Create validation schedules and coordinate execution efforts with operations, facilities, laboratory, development, materials management and quality assurance personnel.
• Translate technical information and requirements into qualification/validation test design
• Lead / support / conduct the execution and generation of (IQ, OQ, PQ, demonstration batches, thermal studies, PV, CV) validation studies for equipment, facilities, utilities, engineering test runs, development studies.
• Independently plan, perform and/or coordinate validation projects to ensure timely completion.
• Provide needed support and / or independently plan, draft, perform and / or coordinate validation projects and execution for equipment / process and / or cleaning validation.
• Prepare and assemble validation packets in accordance with validation department procedures.
• Analyze validation data, prepare summary reports and provide recommendations for improvement in manufacturing process and equipment.
• Actively participates during all phases of validation: evaluates projects, provides technical information to others.
• Write / review technical and quality system documents such as SOPs, Change Control and Deviation Reports as built, flow diagrams as they relate to validation principles and regulatory compliance issues.
• Provide technical assistance during investigations of process /equipment / cleaning / validation issues. Generate and resolve validation deviations / protocol discrepancies.
• Support, investigate and troubleshoot problems and determine possible solutions.
• Identify, respond, monitor potential project risk, and determine possible contingency plans for risk mitigation.
• Provides tracking, review and management of project deliverables.

Confidential, Eatontown, N.J

Manufacturing Engineer

Responsibilities:

• Responsible for providing leadership and establishing capabilities to enable and facilitate successful execution of engineering initiatives critical to cross-functional operational excellence.
• Achieved 6% YoY operating cost reduction by implementing lean manufacturing program and conducting process optimization.
• New products transfer from R&D to production for a successful launch (MagniFuse I, MagniFuse II, & DBF).
• Took successful and innovative lean engineering practices to other sites within the business function and supported implementation of the same.
• Assisted in providing an infrastructure that allows optimization of business benefit, timing, utilization of resources, and cost.
• Partnering cross-functional resources to deliver project objectives to the satisfaction of all stakeholders.
• Lead and supported various efforts with respect to scale up/scale down, tech transfers, EBR development, operations support, deviations/investigations, efficiency projects, third party auditing, device history file record development, SOP/policy development.
• Provided on-going aseptic clean room floor support for all biologic processes by designing and implementing equipment’s with respect to user and process requirements with special emphasis on sterile packaging for all tissue based products.
• Served as a lead in equipment development by providing support and authoring User Requirement Specification (URS), Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) activities.
• For new process and equipment authored user requirements specification (URS); performed risk assessments (FMEA’s).
• Identified & executed scrap project realizing savings by performing retrospective analysis to reduce test samples and increase sellable units.
• Independently investigate and solve day-to-day problems encountered during manufacturing.
• Preparation of qualification summary reports including deviation investigation and resolution.
• Support manufacturing with process improvements, product transfers, manage equipments.
• Co-ordinate with cross-functional groups; QA, QC, Maintenance, Packaging, shipping and planning to ensure uninterrupted production.
• Work closely with suppliers in developing manufacturing processes and equipment for diagnostic products.
• Work independently on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables.
• Improve process efficiency by leading project Value Stream Mapping (VSM) for critical DBM product & manufacturing, identifying efficiency, preparing Boston Matrix & resolving bottleneck in the process.
• Experienced in the generation and execution of IQ, OQ, and PQ protocols, Test Plans, Reports, PES, PRE and Standard Operating Procedures (SOPs) documenting and archiving test results, BOM, Recipe. Create and Utilized PFMEA, tools to perform process improvements.
• Performed training and supervised on the operation of new equipment to manufacturing personnel.
• Received two distinct promotions during the tenure.

Confidential, Somerset, N.J.

Quality Assurance Associate

Responsibilities:

• Ensured compliance to cGMP for all operational activities.
• Conducted annual reviews of product quality, and Coding approval.
• Developed procedures for measuring, testing, and monitoring by micrometer, digital calipers, dial gauges.
• Checked hardness, thickness, and height, do the disintegration for capsules.
• Created / Maintained / Perform calibration requirements.
• Performed data reviews/final report for SOP compliance, review new and updated SOPs.
• Conducted employee training per the site training program (per FDA guidelines).
• Actively supported FDA visits.

Confidential, East Windsor, N.J.

Manufacturing Associate

Responsibilities:

• Inspected & Installed Temp Probe Cable, Temp Probe Towers, Chamfer Stiffener on Probe Cable, final test on scatter graph.
• Analyzed schematic diagrams.
• Extensively used gauges, micrometer, and calipers for testing.
• Soldered electrical components built & tested auxiliary equipment that supports blood analyzers used in hospitals.