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Lab Capa Validation Engineer Resume

Queensbury, NY

SUMMARY

  • Over 6 years of diversified experience in Technical Writing, Validation procedures and Quality Assurance in Pharmaceutical Industry with a strong background in performing Equipment Validation, Commissioning and Qualification, Cleaning Validation and Computer System Validation.
  • Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the remediation plans to mitigate the non compliance.
  • Strong knowledge of FDA 21CFR Part 11: Electronic records and electronic signatures along with 21 CFR Part 50, 56, 58, 210, 211, 312, 314, 820.
  • Validated QC lab equipment per USP section 1058, FDA part 11, 210, 211, 820.
  • Experience in developing Validation deliverables in compliance with cGMP, GAMP, cGLP, and cGCPs.
  • Subject matter expert (SME) in equipment validation.
  • Expertise in preparing Risk Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
  • Experience with entire life cycle of Computer Systems Validation including User Requirement Specifications (URS), Functional Requirements Specifications (FRS) Vendor Assessment (VA) and System Confidential Specifications (SDS).
  • Experience in periodic review of the systems for Validation maintenance.
  • Experience in developing protocols, Executing tests and Summary Reports for IQ, OQ and PQ for validations in various pharmaceutical companies.
  • Identified Exceptions in SAT and addressed deviations by Corrective and preventive actions Plan (CAPA).
  • Development and Execution of Process and Cleaning Validation & Verification protocol.
  • Extensive experience in writing and reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs) and Requirement Traceability Matrix (RTM).

PROFESSIONAL EXPERIENCE

Confidential, Queensbury, NY

Lab CAPA Validation Engineer

Responsibilities:

  • Prepared and executed IQ, OQ, and PQ qualifications for production equipment and process methods.
  • Provided consulting services on strategies for CAPA reduction and closure including change control for critical systems and equipment process using Track Wise to monitor status of CAPA's.
  • Experience includes IQ/OQ technical writing and execution, commissioning, change control administration and SOP adherence.
  • Performed Gap Analysis, documented and defined the gaps and wrote Remediation Plan to bring the system in compliance with 21 CFR Part 11 Regulation and participated in preparing the implementation plan
  • Function as Subject Matter Expert (SME) in areas including aseptic processing, shipping validation and cleaning validation during internal and external audits, and as validation SME for regulatory agency audits required for compliance of validated equipment, processes and systems. Participate in CAPA and deviation program as validation SME.
  • Involved with Confidential Qualifications meetings and ensure post - meeting follow up with SME's and Quality to ensure DQR's are approved.
  • Updated standard TMV procedures to bring up to current quality system regulations
  • Works with Quality to address Product Quality, determine Root Cause and fulfil the requirements of the TMV CAPA
  • Performed Gap Analysis, documented and defined the gaps and wrote Remediation Plan to bring the system in compliance with 21 CFR Part 11 Regulation and participated in preparing the implementation plan
  • Prioritize, analyze and resolve technical issues during IQ/OQ/PQ execution and develop effective solutions.
  • Experienced in IQ/OQ/PQ/TMV/Software Validation in manufacturing
  • Working knowledge in ISO 13485 Medical devices - Quality management systems
  • Proficient in Risk Management, DFMEA, PFMEA, and CAPA.

Confidential

Lab Quality Engineer

Responsibilities:

  • Directed and managed the daily operation & activities of the lab and technician staff to leak test and document field and validation components.
  • Conduct failure analysis on field return & validation components and issue detailed reports on findings.
  • Provided scientific support as validation SME in the resolution of investigations and development ofCAPA's.
  • Managing quality Control Lab and all laboratory equipment and quality assurance projects;
  • Proactively coordinate and engage in discussions on test results with cross-functional teams for high-level issue identification & root cause analysis.
  • Delegate critical issues to subject matter experts and Confidential engineers for resolution and oversee the work performed by lab support staff.
  • Extensive interaction with 3rd party vendor, IT, Users, SME, Business Owners, and QA departments to develop and maintain validation procedures and get the validation documents reviewed and approved. Also reviewed executed test Scripts and scenarios.
  • Recorded deviations/investigations, CAPA for any discrepancies observed during execution of Cleaning, Process and Packaging Validation Protocols.
  • Develop new test procedures and Confidential fixtures for testing various cooling system components.
  • Performs ongoing non-conformance investigations in the Trackwise-CAPA System using root cause analysis.

Confidential

Medical Device Engineer

Responsibilities:

  • Developed and maintained SPC database.
  • Ability to oversee the documentation of nonconformities, trending of company processes, as well as documented non conformance's into the Corrective Action/Preventative Action (CAPA) program.
  • Responsible for conducting and closing investigations, determining root cause, and implementing/closing CAPAs.
  • Maintained, reviewed, and updated the company on the latest standards (ASTM/AAMI), guidance, and applicable requirements from regulated bodies (FDA/ISO).
  • Authored Test Protocols and performed Test Method Validations for mechanical devices.
  • Validated Test Fixtures, Test Assemblies and Gauges.
  • Reviewed validation (IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensure validation reports were qualified to company and regulatory requirement
  • Performed GAP Analysis and developed Remediation Plan for compliance with FDA regulations
  • Issue tracking and Reporting to the feature leads/SME.
  • Address needs for product Supplier Notice of Change testing, Confidential /model test articles (in Pro/E), draft studies using good documentation practices (GDP).
  • Assisted in SOPs, CAPA, OOS Investigation, root cause analysis
  • Responsible for product Confidential reviews and mold transfer process.
  • Assisted product development in quality control procedures, development of test protocols for new equipment procurements (IQ/OQ/PQ), and introducing best practices to manufacturing.
  • Developed and maintained QAR (Quality Assurance Report) books.

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