Process Validation Engineer Resume
Objective : Provide process engineering support to Product Engineering, Product Development, Product Management, and Quality Control in the development of new products and the maintenance of customer relationships as well as company quality standards.
Skills : Technical Knowledge, Analytical.
Description :
- Applied data-driven problem-solving techniques where required to address complex problems.
- Executed process improvement projects to increase line efficiencies, reduce cost variances, increase product margins, and improve quote competitiveness.
- Performed material compatibility and characterization testing to assist in the mechanical design, ensuring the optimal selection of materials for specific applications.
- Drove development of Proof of Principle (PoP) projects through to full-scale production that enabled improved battery performance, quality, and cost.
- Implemented Engineering Change Orders on existing machinery to unlock capacity and improve Overall Equipment Effectiveness (OEE).
- Led the process commissioning on new production lines through factory acceptance testing (FAT) and site acceptance testing (SAT).
- Worked with production staff and engineers to develop, validate, and improve processes used in manufacturing and manufacturability of designs.
Experience
0-2 Years
Level
Entry Level
Education
Bachelor's degree in Chemical Engineering
Senior Process Validation Engineer Resume
Summary : As a Process Validation Engineer, collaboration with validation management, assist internal project teams and external validation firms on Validation/qualification initiatives and to ensure project schedules are met.
Skills : Problem-Solving, Communication.
Description :
- Debugged process integration issues to ensure interactions between processes were kept under control.
- Built process documentation to accurately define the process to cross-functional teams (equipment, quality, production).
- Developed and supported the detailed project plans and timelines for the execution of process validation activities.
- Prepared validation and change control documentation, including protocols, summary reports.
- Compiled trace matrices, performed data analysis, drafted validation protocol discrepancy reports, and drafted process validation summary reports.
- Participated in client and Regulatory Audits.
- Worked on CAPA and QS with minimal oversight to achieve timely results.
Experience
10+ Years
Level
Senior
Education
Bachelor's degree in Industrial Engineering
Process Validation Engineer Resume
Summary : As a Process Validation Engineer, works closely with other validation department personnel and cross-functionally with MTS, Manufacturing, Engineering, QC, Quality Assurance, and project management to achieve all project deliverables.
Skills : Attention to Detail, Regulatory Compliance.
Description :
- Assisted with determining the impact of change control on qualified process and aseptic operations.
- Assisted management with mentoring and training of colleagues on policies and procedures including the requirements for validation.
- Performed all functions associated with process validation support.
- Developed and recommended science-based solutions with a focus on continuous improvement and compliance.
- Wrote process validation and process simulation media fill protocols and technical study approaches.
- Coordinated business activities and assigned business tasks to support executions.
- Evaluated proposed changes to validated systems and recommended the level of validation required.
Experience
7-10 Years
Level
Management
Education
Bachelor's degree in Chemical Engineering
Associate Process Validation Engineer Resume
Objective : As a Process Validation Engineer, performs risk assessment and mitigation steps to achieve validation requirements and ensure each process remains in a validated state of compliance by compiling and analyzing data for continued process verification.
Skills : Project Management, Collaboration, Risk Assessment.
Description :
- Led all aspects of project management activities for validation projects process within the scope of an overall system project.
- Assisted with the development of system requirements and specifications to ensure requirements were testable and met.
- Implemented or coordinated the execution of validation plans and validation documents.
- Coached the implementation teams in the proper execution of validation documents.
- Developed comprehensive plans to validate medical devices, aligning with regulatory requisites and company protocols.
- Crafted validation protocols including IQ, OQ, PQ, and VMP in accordance with product specifications and regulatory standards.
- Conducted thorough validation testing and inspections to verify equipment, processes, and systems met predetermined criteria.
Experience
2-5 Years
Level
Executive
Education
Bachelor's degree in Chemical Engineering
Process Validation Engineer Resume
Objective : As a Process Validation Engineer, coordinates and executes validation protocol activities with consistent and effective communication with affected departments, working autonomously while keeping the manager updated regularly.
Skills : Continuous Improvement, Technically minded.
Description :
- Identified potential risks in the validation process and strategized mitigation tactics for optimal product quality.
- Analyzed validation data, ensuring accuracy and compliance, and recommended corrective actions or process enhancements.
- Maintained meticulous documentation of validation activities and prepared detailed reports for regulatory review.
- Collaborated with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing to ensure alignment of validation activities with project goals.
- Stayed abreast of relevant regulations and standards, ensuring adherence to validation requirements.
- Identified opportunities for process optimization and implemented best practices to enhance validation efficiency.
- Provided guidance to team members on validation principles and mentored junior engineers.
Experience
0-2 Years
Level
Junior
Education
Bachelor's degree in Mechanical Engineering
Process Validation Engineer Resume
Objective : develop and implement quality control procedures, monitor equipment, and analyze test data. Depending on their area of specialization, they may be employed in the aerospace, automotive, biotechnology, computer software, or pharmaceutical industries.
Skills : Knowledge of production processes.
Description :
- Supported internal and external audits, ensuring audit readiness and facilitating responses.
- Evaluated proposed changes and implemented procedures to update validation documentation.
- Measured production processes and parameters against industry standards.
- Established validation standards and developed performance testing and quality control measures.
- Calibrated equipment to function within acceptable parameters.
- Developed test procedures that produced analyzable validation data.
- Analyzed test data to determine the causes of defects, failure, or flaws and facilitated corrective measures.
Experience
0-2 Years
Level
Fresher
Education
Bachelor's degree in Mechanical Engineering
Process Validation Engineer Resume
Summary : As a Process Validation Engineer, monitors systems, equipment and processes used in pharmaceutical contexts, especially in manufacturing. Works in collaboration with process or CSV engineers, scientists or QA specialists.
Skills : Strong maths skills, Good IT skills.
Description :
- Performed risk assessments and ensured compliance with industry standards.
- Conducted preventative maintenance, as well as repaired or replaced equipment.
- Presented validation test results and recommended improvements.
- Trained staff on validation parameters, oversaw validation technicians, and documented processes.
- Kept informed of developments and innovation in validation engineering.
- Tested the proper functioning of equipment and resolved any issues, including making adjustments or improvements.
- Maintained the correct calibration and other parameters of instrumentation and equipment.
Experience
7-10 Years
Level
Consultant
Education
Bachelor's degree in Industrial Engineering
Process Validation Engineer Resume
Objective : As a Process Validation Engineer, performs validation functions to ensure accurate and timely completion with frequent decision making, coordination and communications.
Skills : Root cause analysis, Data analysis.
Description :
- Correctly interpreted customer requirements, and initiated and supervised validation activities.
- Created databases and validation schedules to track validation activities.
- Documented test results and performed analyses.
- Prepared compliance, analysis, and other reports.
- Developed Validation master plans for various projects.
- Designed and implemented various validation assessment procedures according to required validation protocols.
- Coordinated with equipment vendors and assisted in process fabrication and prepared appropriate reports for approvals.
Experience
0-2 Years
Level
Junior
Education
Bachelor's degree in Chemical Engineering
Process Validation Engineer Resume
Summary : As a Process Validation Engineer, manages, inspects, calibrates, tests and modifies the instrumentation, equipment, mechanics, and systems that manufacture various products.
Skills : Equipment calibration, Quality management.
Description :
- Collaborated with the validation team and identified the turnover of validated systems and processes.
- Assisted project manager in all validation plans for projects and determined all resources required for validation.
- Monitored all automation processes and prepared specifications for all equipment.
- Maintained knowledge of all industry trends for validation process and development.
- Prepared project schedules and implemented protocols for validation.
- Developed test strategies for validation products and media equipment requirements and designed methodology appropriately.
- Administered all predetermined work assignments associated with validation tools and procedures.
Experience
7-10 Years
Level
Consultant
Education
Bachelor's degree in Mechanical Engineering
Process Validation Engineer Resume
Summary : As a Process Validation Engineer, responsible for developing, implement and maintaining validation processes, determining validation control, preparing validation protocol, qualifying process verification techniques, and maintaining validation standards.
Skills : Windows operating systems, and SQL Server.
Description :
- Developed and implemented various validation guidelines and document packages for all assignments.
- Implemented all validation processes according to standard operating procedures.
- Maintained and performed calibration on all validation test equipment and processes.
- Coordinated with various validation work tasks and prepared reports to submit to management.
- Analyzed processes, identified all processes, and evaluated all resources.
- Led multiple complex validation activities associated with computers, equipment, and processes.
- Coordinated validation-associated audit activities; established rationales and technical defense positions.
Experience
7-10 Years
Level
Management
Education
Bachelor's Degree in Business
