Validation Specialist Job
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Employer: MMR Consulting USA Inc
SpiderID: 14145807
Location: Orland Park, Illinois
Posted: 2/24/2026
Wage:
Priority Review Date: 5/25/2026
Job Code / NOC / SOC: SA2025
Category: Engineering
Job Description:
• Authored and executed C&Q protocols, and C&Q documentation (URS, risk assessments, RTM, DQ) in compliance with regulations.
• Verification of Drawings, P&ID walkdowns, component verification, turnover documentation verification.
• Start-Up Support; Developed and/or updated SOPs, Work Instructions, Change controls, training material, review and drafting PMs, spare parts, and bill of materials documentation.
• Drafted SOPs for operation and maintenance of HVAC and electrical equipment for critical utilities.
• Initiated and closed change controls
• Utilized Veeva software, Kneat, Smartsheets, Sharepoint, and MS Office Suite.
• Authored plans for Asset Management and Preventive Maintenance of critical utilities equipment like TOC-Analyzers, pressure safety regulators, pumps, diaphragm and other safety valves on SAP.
• Supported capital projects by participating in setting equipment criteria and specifications to analyze system reliability.
• Coordinated with production to complete equipment repairs, and PM’s during opportunistic and scheduled downtime events
• Ensure full compliance with FDA regulations, GAMP, and 21 CFR Part 11 standards across all validation and commissioning activities.
• Use skills including: QMS (TrackWise, VeevaVault), Kneat, Valgenesis, Good Documentation Practices, ALCOA++, ISO 9001, ISO 13485, ISO 14971, 21 CFR Part 11, OSHA – 29 CFR 1910, ASME, ANSI, ASTM E2500, cGMP, GAMP, Lean Six Sigma Principles, Continuous Improvement, Measurement System Analysis, Statistical Process Control, Hazard and Risk Analysis (Fault Tree Analysis, FMEA).
• Verification of Drawings, P&ID walkdowns, component verification, turnover documentation verification.
• Start-Up Support; Developed and/or updated SOPs, Work Instructions, Change controls, training material, review and drafting PMs, spare parts, and bill of materials documentation.
• Drafted SOPs for operation and maintenance of HVAC and electrical equipment for critical utilities.
• Initiated and closed change controls
• Utilized Veeva software, Kneat, Smartsheets, Sharepoint, and MS Office Suite.
• Authored plans for Asset Management and Preventive Maintenance of critical utilities equipment like TOC-Analyzers, pressure safety regulators, pumps, diaphragm and other safety valves on SAP.
• Supported capital projects by participating in setting equipment criteria and specifications to analyze system reliability.
• Coordinated with production to complete equipment repairs, and PM’s during opportunistic and scheduled downtime events
• Ensure full compliance with FDA regulations, GAMP, and 21 CFR Part 11 standards across all validation and commissioning activities.
• Use skills including: QMS (TrackWise, VeevaVault), Kneat, Valgenesis, Good Documentation Practices, ALCOA++, ISO 9001, ISO 13485, ISO 14971, 21 CFR Part 11, OSHA – 29 CFR 1910, ASME, ANSI, ASTM E2500, cGMP, GAMP, Lean Six Sigma Principles, Continuous Improvement, Measurement System Analysis, Statistical Process Control, Hazard and Risk Analysis (Fault Tree Analysis, FMEA).
Job Requirements:
Education: Master of Science degree in Industrial Technology, or Industrial Engineering.
Experience:
- One year of experience in validating manufacturing equipment used in the medical device industry to ensure compliance with regulatory and quality standards;
- One year of experience in utilizing methodologies including Failure Mode and Effects Analysis (FMEA), Gap Analysis, and Change Control;
Skills and knowledge: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Contact: HR, MMR Consulting USA, Inc., 15255 South 94th Avenue, Orland Park, IL 60462. Ref # SA2025
Experience:
- One year of experience in validating manufacturing equipment used in the medical device industry to ensure compliance with regulatory and quality standards;
- One year of experience in utilizing methodologies including Failure Mode and Effects Analysis (FMEA), Gap Analysis, and Change Control;
Skills and knowledge: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Contact: HR, MMR Consulting USA, Inc., 15255 South 94th Avenue, Orland Park, IL 60462. Ref # SA2025
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Experience: 0-1
Education: Masters
Travel:
Vacation:
Company Profile:
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).
Contact Information:
| Contact Name: Neha Kumari | Type: Employer |
| Company: MMR Consulting USA Inc |