Validation Engineer Resume Samples

Description :

1. Perform commissioning and validation for a new manufacturing facility and author qualification protocols.
2. Develop risk assessments, deviation responses, and summary reports for qualification activities.
3. Execute equipment validation for facilities, cold rooms, HVAC, CIP, COP, critical utilities and laboratory equipment.
4. Executed temperature mapping studies and engineering test plans prior to validation activities.
5. Designed experiments and authored protocols, summary documentation, change controls and regulatory documentation.
6. Managed deviation and non-conformance reports and investigations. Scheduled project activities in concert with the production schedule while meeting all milestones.
7. Implemented and executed qualification procedures for chromatography systems, clean steam, dispensing stations, WFI, HVAC, CIP, SIP, COP, UF/DF Skids, cold storage rooms, fume hoods, floor scales, and critical utilities.
8. Performed a variety of general validation activities, including the IQ/OQ/PQ activities for equipment such as agitators/mixers, bench scales, centrifuges, and storage vessels.

Experience

7-10 Years

Level

Senior

Education

Bachelors Of Science

Description :

1. Performed risk management activities using Failure Mode Effect Analysis (FMEA) techniques to identify potential failure modes on pharmaceutical and medical device manufacturing equipment.
2. Established and maintained procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability.
3. Performed process capability studies with Ppk & Cpk indexes to analyze processes using statistical software.
4. Authored protocols and reports; specific to the validation of test methods Experienced in working with suppliers for the development of inspection methods Responsible for initiating, implementing and completing change control, deviations, investigations, impact/risk assessments, root cause analysis, and CAPAs.
5. Responsible for maintaining Quality System Regulations (Part 820) and Regulatory Standards (ISO) Responsible for reviewing the design and process changes and assess impact to assure reliability requirements are met.
6. Authored operational, maintenance and calibration procedures for production equipment, test equipment, and utilities.
7. Validated test methods and analyzed the data using Gage R&R and Anova studies.

Experience

5-7 Years

Level

Executive

Education

Bachelor Of Science

Description :

1. Assist in the maintenance, repair, commissioning and Qualification of RO and WFI purified water systems.
2. Providing Engineering support for existing WFI and RO purified water systems to fix or improve performance.
3. Generating Standard Operating Procedures (SOP) and Preventative Maintenance (PM) programs for WFI / RO purified water system Providing engineering and consulting services on project-related issues for clients.
4. Write protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment Develop/review of various validation documentation including URS, FRS, DDS, SOP, IQ, OQ, PQ, Traceably Matrices and Summary Reports.
5. Packaging line Pharmaceutical Equipment Validation Performed Computer System Validation on OnBase Software Systems Building Automation System (BAS) Qualification Equipment PLC Setup and verification.
6. Walk-in Refrigerators and Freezers Qualification.
7. Ensure that all deviations to protocols and/or deviations to acceptance criteria are adequately addressed (documented and reviewed) by the Validation Committee.

Experience

2-5 Years

Level

Junior

Education

Bachelor Of Science

Description :

1. Perform commissioning and validation for a new manufacturing facility and author qualification protocols.
2. Develop risk assessments, deviation responses, and summary reports for qualification activities.
3. Execute equipment validation for facilities, cold rooms, HVAC, CIP, COP, critical utilities and laboratory equipment.
4. Executed temperature mapping studies and engineering test plans prior to validation activities.
5. Designed experiments and authored protocols, summary documentation, change controls and regulatory documentation.
6. Managed deviation and non-conformance reports and investigations. Scheduled project activities in concert with the production schedule while meeting all milestones.
7. Implemented and executed qualification procedures for chromatography systems, clean steam, dispensing stations, WFI, HVAC, CIP, SIP, COP, cold storage rooms, fume hoods, floor scales, and critical utilities.
8. Performed a variety of general validation activities, including the IQ/OQ/PQ activities for equipment such as agitators/mixers, bench scales, centrifuges, and storage vessels.

Experience

7-10 Years

Level

Senior

Education

Bachelors Of Science

Description :

1. Served as a consultant on various client projects, including validating process control systems, laboratory equipment, and computer software and performing document remediation.
2. Developed and executed IQ/OQ protocols for Emerson DeltaV process control systems.
3. Documented test methods for automation errors identified during commissioning activities.
4. Created, executed, and closed out validation activities for laboratory equipment such as Emax microplate readers, analytical balances, incubators, titrators, viscometers, moisture analyzers, polarimeters, muffle furnaces, ovens, autoclaves, pH meters, refrigerators, HPLCs, GCs, spectrophotometers, Agilent UV-Vis, pipetting machine, dissolution testing station, and interface validation module.
5. Drafted SOPs for validated laboratory equipment.
6. Facilitated development and implementation of warehouse and order management software systems.
7. Assessed validation documents against customer guidelines and made recommendations, as necessary.
8. Supported change control and remediation of existing instrumentation validation documents.

Experience

7-10 Years

Level

Senior

Education

Bachelor Of Science

Description :

1. Review and approves validation documentation, protocols, and reports.
2. Provide the execution scope outlined in the validation protocols, including the collection, review, analysis of tests and verification of submitted data and reports.
3. Participates in the validation process and protocols execution of existing and new GMP manufacturing equipment, optical tooling instruments, autoclaves, and computerized systems.
4. Serve as the subject matter expert (SME) on manufacturing equipment/systems and instrument qualifications and validations non-compliance issues, such as protocol discrepancies/deviations, non-conformance reports (NCR's) and troubleshooting/solving activities.
5. Review Engineering Studies as pertains to the qualification of existing and new GMP manufacturing equipment, optical tooling instruments, autoclaves, and computerized systems, as applicable.
6. Assess the impact of proposed changes to cGMP related systems.
7. Suggest/implement corrective actions/preventive actions as needed to maintain cGMP/FDA regulation and Site policies and procedures.

Experience

2-5 Years

Level

Junior

Education

Bachelor Of Science

Description :

1. Provided design, analysis, testing and validation for brake systems, steering and suspension, chassis power train and fuel systems as well as exterior systems.
2. Analyzed product design and launched the best method for manufacturing brake system products for prestige and performance vehicles.
3. Directed design, development and improvement of manufacturing processes and provided technical support for specific operations.
4. Implemented operating procedures, resolved system malfunctions, and provided technical information for staff.
5. Coordinated information from internal and external customers to enhance market penetration and customer satisfaction.
6. Developed and tested models of alternate designs and processing methods to assess feasibility, operating condition effects, possible new applications and necessity for further changes and modification.
7. Maintained current knowledge of product developments and trends and actively identified new areas of information.
8. Streamlined processes and contain costs for new equipment associated with the department.

Experience

10+ Years

Level

Consultant

Education

Bachelors Of Science

Description :

1. Prepared a Validation Master Plan (VMP) for validating the Trackwise application.
2. Involved in the complete system development life cycle and documentation.
3. Authored User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) by closely working with Business Analyst.
4. Developed and reviewed Standard Operating Procedures (SOPs) for various functionalities of the system Reviewed the Test Strategy document prepared by the testing team and provided input on the validation requirements.
5. Involved in creation, execution and responsible for pre and post-execution review of Unit Test scripts, Performance/Automated Test Scripts, Regression Test Scripts, IQ/OQ/PQ Test Scripts and UAT Test Scripts.
6. Analyzed test scripts to check whether all functionalities have been covered within the compliance of 21 CFR Part 11 Responsible for Test Case Development, Execution and summarizing the results following strict FDA regulation - 21 CFR Part 11.
7. Participated in system test script execution and documented results.

Experience

2-5 Years

Level

Junior

Education

Bachelor Of Science

Description :

1. Designed, implemented and validated 21 CFR Part 11 compliance strategies for LIMS.
2. Played a major role in performing part 11 assessment, especially contributing to the components involved in the maintenance of Electronic Records (ER), Electronic Signatures (ES) and Audit Trails in accordance with 21 CFR part 11 regulations.
3. Provided system support and configuration support required to maintain quality management solution.
4. Wrote the technical specifications for new business processes, updated technical specs for improvement and generated validation documentation.
5. Authored and reviewed the procedures pertaining to Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols for the LIMS application.
6. Analyzed User and Functional requirements to develop Test Plans, Test Cases and Test Scripts using HP ALM and executed them.
7. Executed validation test cases based on system requirements and FDA standards.
8. Performed functionality testing for the entire application.

Experience

5-7 Years

Level

Executive

Education

Bachelor Of Science

Description :

1. Initiated cleaning validation protocols and reports.
2. Updated, edited and circulated the Validation Master Plan, and associated SOPs.
3. Initiated process validations, and engineering reports.
4. Developing cleaning procedure for various process vessel and mixing tanks Generate, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.
5. Assigned equipment swab points for various pharma equipment Generation and evaluation of SOP and CAPA.
6. Execution of FMEA and Validation Master Plan.
7. Developing a cleaning cycle for formulation equipment - homogenizer, high shear mixer and tanks.
8. Proficient in determining cleaning MAC (Maximum allowable carryover) limits to establish acceptance criteria for cleaning of equipment Performed Calculation of acceptable residual limits of the Active Ingredients (API) and Detergent.
9. Designed, performed the Visual Inspection Test method to determine the acceptance criteria of the cleaning validation protocol of manufacturing equipment.

Experience

5-7 Years

Level

Executive

Education

Masters of Science