Validation Engineer job Rensselaer New York
Validation Engineer job Rensselaer New York
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Validation Engineer Job


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Employer Name: ND Global Consulting Services Inc SpiderID: 13980031
Location: Rensselaer, New York Date Posted: 4/17/2025
Wage: 92810 Category: Biotech
Job Code:
Number Of Openings: 1

Job Description:
Validation Engineer is needed to perform the following duties:


• Responsible for developing protocols and reports for IQ, OQ and PQs for Water systems, HVAC, Utilities, Steam sterilizers, Tunnel sterilizers, Filling systems, Extruder, Spiralizer, Bioreactors/fermenters, isolators, autoclaves, and Laboratory systems

• Perform annual revalidation for steam sterilizers (Autoclaves), Tank Stations and dry heat sterilizers using Kaye validation system.

• Develop new sterilization cycles as needed. Work on SIP validation of bioreactors, filtration systems and (Cycle development, Temperature mapping and BI evaluation, Fo and SAL calculations).

• Develop the CIP system qualification protocols for the new equipment. (Spray Ball coverage test-Riboflavin fluorescence test, cleaning cycle development and validation).

• Execution for temperature mapping for Cold Rooms, Freezers, warehouses, Incubators, and stability chambers.

• Perform IQ, OQ, PQ of Bioreactors, Refrigerators, coolers, Autoclaves, freezers, flow hoods, BSC, incubators, mixers.

• Prepare Functional and component criticality assessment completion for equipment used in sterile manufacturing.

• Execute critical test protocol including empty and loaded chamber by temperature mapping using thermocouples, data loggers and Kaye validator.

• Experience in Corrective Action Preventive Action (CAPA), Change Control, and Document Management Process.

• Development and execution of CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.

• Startup equipment in a safe and effective manner.

• Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.).

• Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement.

• Specifications, Turnover Packages, and other regulatory support documentation.

• Perform risk assessments and impact assessments.

• Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients.

• Looking for a resource that has experience with:

-Single Use Technology

-Bioreactors

-Filtration Skids

-Autoclaves Etc.

• Development and execution of CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.

• Provide CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices.

• Develop CQV planning documents to manage CQV projects.

• Generate and execute CQV protocols using Good Documentation Practices (GDPs).

• Investigate and resolve protocol exceptions or discrepancies.

• Develop technical reports and CQV summary reports.

• Assist with establishing, reviewing, executing, and ensuring compliance with regulatory requirements, policies, standards, and procedures related to processes of validation and qualification of infrastructure components.

• Establish and/or modify written procedures and standards for critical processes such as quality control, change management, manufacturing, lab practices etc.

• Review existing SOPs, Work Instructions, Protocols, Training Records, System Documentations, Vendor Documents etc. to make sure they are up to date with current regulatory guidelines.

• Development and execution of CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.

• Provide CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices.

• Develop CQV planning documents to manage CQV projects.

• Generate and execute CQV protocols using Good Documentation Practices (GDPs).

• Investigate and resolve protocol exceptions or discrepancies.

• Develop technical reports and CQV summary reports.

• Assist with establishing, reviewing, executing, and ensuring compliance with regulatory requirements, policies, standards, and procedures related to processes of validation and qualification of infrastructure components.

• Establish and/or modify written procedures and standards for critical processes such as quality control, change management, manufacturing, lab practices etc.

• Review existing SOPs, Work Instructions, Protocols, Training Records, System Documentations, Vendor Documents etc. to make sure they are up to date with current regulatory guidelines.

• Development and execution of CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.

• Startup equipment in a safe and effective manner.

• Perform risk assessments and impact assessments.

• Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients.

• Problem solving and trouble-shooting in Drug Product Validation by conducting research to aid in resolution of issues that arise.

• Perform technical reviews and interpret data for accuracy of performance for completed validations/revalidations.

• Make sure new implementation are qualified in compliance with general industry standards, guidelines and other FDA (Food and Drug Administration) regulations.

• Proficient with Microsoft Office – Word, Excel, PowerPoint, Project.

• Utilize various third party or internally developed software tools such as TrackWise, to track validation activities.

• Ensure these data / document management tools are configured as per current regulatory guidelines (21 CFR Part 11) and internal compliance SOPs to only allow access to authorized users, preserve audit trails and update version controls as necessary.

• Execution of CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.

• Provide CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices.

• Develop CQV planning documents to manage CQV projects.

• Generate and execute CQV protocols using Good Documentation Practices (GDPs).

• Investigate and resolve protocol exceptions or discrepancies.

• Develop technical reports and CQV summary reports.

• Apply knowledge of validation, regulatory affairs and drug manufacturing in general to propose detailed solutions which will show how process or system configuration can change to resolve technical issues found during the root cause analysis.

• Deploying and debugging cloud initiatives as needed in accordance with best practices throughout the development lifecycle.

• Educating teams on the implementation of new cloud-based initiatives, providing associated training as required.

• Employing exceptional problem-solving skills, with the ability to see and solve issues before they snowball into problems.

• Using your extensive knowledge of APIs to design RESTful services, and integrate them with existing data providers, using JSON or XML as needed.

• Lead and develop best practices for larger Cloud Engineer team.

• Orchestrating and automating cloud-based platforms throughout the company.

• Stay current with industry trends, making recommendations as needed to help the company excel.

• Assessing the company's goals.

• Identifying the areas where improvements can be made in the company.

• Researching industry trends.

• Conducting market research.

• Preparing reports on strategy ideas for senior management.


• Present research findings to senior management





Job Requirements:
Bachelor's Degree is required in Pharmacy or Pharmaceuticals Engineering or Pharmaceutical Science.


Job Criteria:
Start Date: 04/21/2025
Position Type: Full-Time Permanent
Years of Experience Required: 3
Education Required: Bachelors
Overnight Travel:
Vacation Time:


Job Benefits:
Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave

Contact Information:
Contact Name: Rashmi Kumari Company Type:
Company: ND Global Consulting Services Inc
City: Tampa
State: Florida
Zip: 33647
Web Site: https://www.ndgcs.com

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