Validation Engineer Job
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Employer: ND Global Consulting Services, Inc
SpiderID: 14188185
Location: Hamilton, Ohio
Posted: 6/1/2026
Wage: $93683 per annum
Priority Review Date: 8/30/2026
Job Code / NOC / SOC: 17-2112.02
Category: General
Job Description:
Validation Engineer is needed to perform the following duties:
* Execute Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ) activities for aseptic fill-finish manufacturing equipment in a GMP-regulated pharmaceutical environment.
* Develop, review, and execute validation protocols, test scripts, and final reports for fill-finish systems, formulation equipment, preparation vessels, and supporting utility systems.
* Perform qualification activities for critical manufacturing equipment, including isolators, autoclaves, parts washers, filling machines, and associated process systems.
* Conduct smoke studies and airflow pattern analyses to verify aseptic processing conditions and ensure compliance with regulatory requirements and industry standards.
* Support startup and commissioning activities for new manufacturing line installations by verifying equipment installation, functionality, and operational readiness.
* Collaborate with Engineering, Manufacturing, Quality Assurance (QA), and Automation teams to resolve validation issues, investigate deviations, and implement Corrective and Preventive Actions (CAPA).
* Generate, review, and maintain GMP documentation, including validation protocols, summary reports, risk assessments, change controls, deviation investigations, and Standard Operating Procedures (SOPs).
* Analyze qualification and validation data to ensure equipment and processes consistently meet predefined acceptance criteria, regulatory requirements, and product quality standards.
* Support formulation, preparation, and fill-finish process validation activities by evaluating critical process parameters and ensuring process reproducibility and consistency.
* Ensure compliance with FDA, cGMP, ICH, and company quality requirements throughout all phases of the validation lifecycle.
* Participate in regulatory inspections and internal audits by providing validation documentation, technical support, and subject matter expertise.
* Conduct gap assessments and drive continuous improvement initiatives to enhance validation processes, equipment reliability, operational efficiency, and overall manufacturing compliance.
* Execute Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ) activities for aseptic fill-finish manufacturing equipment in a GMP-regulated pharmaceutical environment.
* Develop, review, and execute validation protocols, test scripts, and final reports for fill-finish systems, formulation equipment, preparation vessels, and supporting utility systems.
* Perform qualification activities for critical manufacturing equipment, including isolators, autoclaves, parts washers, filling machines, and associated process systems.
* Conduct smoke studies and airflow pattern analyses to verify aseptic processing conditions and ensure compliance with regulatory requirements and industry standards.
* Support startup and commissioning activities for new manufacturing line installations by verifying equipment installation, functionality, and operational readiness.
* Collaborate with Engineering, Manufacturing, Quality Assurance (QA), and Automation teams to resolve validation issues, investigate deviations, and implement Corrective and Preventive Actions (CAPA).
* Generate, review, and maintain GMP documentation, including validation protocols, summary reports, risk assessments, change controls, deviation investigations, and Standard Operating Procedures (SOPs).
* Analyze qualification and validation data to ensure equipment and processes consistently meet predefined acceptance criteria, regulatory requirements, and product quality standards.
* Support formulation, preparation, and fill-finish process validation activities by evaluating critical process parameters and ensuring process reproducibility and consistency.
* Ensure compliance with FDA, cGMP, ICH, and company quality requirements throughout all phases of the validation lifecycle.
* Participate in regulatory inspections and internal audits by providing validation documentation, technical support, and subject matter expertise.
* Conduct gap assessments and drive continuous improvement initiatives to enhance validation processes, equipment reliability, operational efficiency, and overall manufacturing compliance.
Job Requirements:
Bachelor's Degree is required in Pharmacy or Pharmaceutical Engineering or Biomedical Engineering.
Job Criteria:
Start Date: 06/29/2026
Position Type: Full-Time Permanent
Experience: 2-5
Education: Bachelors
Travel: More Than 75%
Vacation: No Paid Vacation
Job Benefits:
Health/Dental Benefits, Relocation Assistance, Offers Sponsorship for U.S. Visa
Contact Information:
| Contact Name: Rashmi Kumari | Type: Employer |
| Company: ND Global Consulting Services, Inc. | |
| Web Site: https://www.ndgcs.com | |