Description
Hello Everyone
We at CosMicIT are urgently looking for OT Validation Resources
Locations: #CA #Vacaville
Experience: 5-10Years
Job Type: Remote
Job Description
We are seeking an experienced MES/OT Validation Engineer with strong expertise in validating Operational Technology (OT) systems including Rockwell Automation PLCs, HMIs, and SCADA. This role is responsible for the planning, development, execution, and documentation of validation protocols to ensure systems are compliant with 21 CFR Part 11, GAMP 5, and relevant industry standards.
This role also requires close collaboration with process engineering, QA, and MES teams to design aligned with GMP and 21 CFR Part 11 compliance.
Key Responsibilities:
Lead and execute validation activities for OT systems and its Integration with MES in regulated manufacturing environments (e.g., pharmaceutical, biotech, medical devices, or food & beverage).
Develop and maintain Validation Master Plans (VMPs), User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, and Traceability Matrices.
Validate Rockwell Automation hardware and software components including:
PLCs (e.g., ControlLogix, CompactLogix)
HMI (e.g., FactoryTalk View ME/SE)
SCADA systems (e.g., FactoryTalk SE, FT Historian, FT VantagePoint)
Interface with MES vendors and integrators to support system implementation and validation.
Collaborate cross-functionally with QA, IT, Automation, and Manufacturing to ensure validation deliverables meet project timelines and regulatory expectations.
Perform risk assessments and support deviation investigations and change control processes.
Maintain validation documentation in compliance with FDA, EU Annex 11, and internal SOPs.
Support audits and inspections by providing validation records and rationales.
Technical Skills Required:
Bachelor's degree in engineering, Computer Science, or a related field.
5+ years of experience in MES/OT system validation in a regulated manufacturing environment.
Strong knowledge of Rockwell Automation platforms (PLC, HMI, SCADA).
Solid understanding of CSV principles, GAMP 5, and 21 CFR Part 11 compliance.
Experience with automation systems integration and industrial networking.
Proficiency in technical writing and documentation.
Preferred Qualifications:
Experience with MES platforms (e.g., Rockwell PharmaSuite).
Familiarity with ISA-95/ISA-88 standards.
Knowledge of cybersecurity principles in OT environments.
Experience using ALM tools (e.g., ValGenesis, MasterControl, HP ALM).
Soft Skills:
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Detail-oriented with a focus on compliance and quality.
Ability to work independently and manage multiple priorities in a fast-paced environment.
Eligible candidates, please share their resume/CV at
Any references would also be accepted.
Thanks & Regards,
CosMicIT GmbH, Germany
CosMicIT Informatics India Pvt Ltd.
CosMicIT Spolka Z Ograniczona Odpowiedzialnoscia, Poland
www.CosMic-IT.com | www.CosMic-IT.in
LinkedIn: https://www.linkedin.com/company/cosmic-it/
We at CosMicIT are urgently looking for OT Validation Resources
Locations: #CA #Vacaville
Experience: 5-10Years
Job Type: Remote
Job Description
We are seeking an experienced MES/OT Validation Engineer with strong expertise in validating Operational Technology (OT) systems including Rockwell Automation PLCs, HMIs, and SCADA. This role is responsible for the planning, development, execution, and documentation of validation protocols to ensure systems are compliant with 21 CFR Part 11, GAMP 5, and relevant industry standards.
This role also requires close collaboration with process engineering, QA, and MES teams to design aligned with GMP and 21 CFR Part 11 compliance.
Key Responsibilities:
Lead and execute validation activities for OT systems and its Integration with MES in regulated manufacturing environments (e.g., pharmaceutical, biotech, medical devices, or food & beverage).
Develop and maintain Validation Master Plans (VMPs), User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, and Traceability Matrices.
Validate Rockwell Automation hardware and software components including:
PLCs (e.g., ControlLogix, CompactLogix)
HMI (e.g., FactoryTalk View ME/SE)
SCADA systems (e.g., FactoryTalk SE, FT Historian, FT VantagePoint)
Interface with MES vendors and integrators to support system implementation and validation.
Collaborate cross-functionally with QA, IT, Automation, and Manufacturing to ensure validation deliverables meet project timelines and regulatory expectations.
Perform risk assessments and support deviation investigations and change control processes.
Maintain validation documentation in compliance with FDA, EU Annex 11, and internal SOPs.
Support audits and inspections by providing validation records and rationales.
Technical Skills Required:
Bachelor's degree in engineering, Computer Science, or a related field.
5+ years of experience in MES/OT system validation in a regulated manufacturing environment.
Strong knowledge of Rockwell Automation platforms (PLC, HMI, SCADA).
Solid understanding of CSV principles, GAMP 5, and 21 CFR Part 11 compliance.
Experience with automation systems integration and industrial networking.
Proficiency in technical writing and documentation.
Preferred Qualifications:
Experience with MES platforms (e.g., Rockwell PharmaSuite).
Familiarity with ISA-95/ISA-88 standards.
Knowledge of cybersecurity principles in OT environments.
Experience using ALM tools (e.g., ValGenesis, MasterControl, HP ALM).
Soft Skills:
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Detail-oriented with a focus on compliance and quality.
Ability to work independently and manage multiple priorities in a fast-paced environment.
Eligible candidates, please share their resume/CV at
Any references would also be accepted.
Thanks & Regards,
CosMicIT GmbH, Germany
CosMicIT Informatics India Pvt Ltd.
CosMicIT Spolka Z Ograniczona Odpowiedzialnoscia, Poland
www.CosMic-IT.com | www.CosMic-IT.in
LinkedIn: https://www.linkedin.com/company/cosmic-it/