Validation Support Engineer - cGxPServe : Job Details

2 weeks ago Be among the first 25 applicants

• We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment.
• The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards.

Job Description

• We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment.
• The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards.

Responsibilities:

• Develop/update Validation Plans (VP) and Master Validation Plans (MVP).
• Lead GxP risk assessments for system changes.
• Author and execute IQ/OQ/PQ protocols.
• Maintain Requirements Traceability Matrices (RTM).
• Investigate and manage deviations; support RCA and CAPA processes.
• Create Validation Summary Reports (VSR).
• Ensure full compliance with regulatory and quality standards.

Requirements:

• 5 8 years of experience in Computer System Validation (CSV).
• Strong knowledge of FDA regulations and GAMP5.
• Hands-on experience validating PLC-controlled systems.
• Beckhoff Twin CAT PLC and Ether CAT hardware experience is a strong plus.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionInformation Technology
• IndustriesResearch Services

Referrals increase your chances of interviewing at cGxPServe by 2x

Sign in to set job alerts for “Support Engineer” roles.

Boston, MA $76,000.00-$96,000.00 3 months ago

Boston, MA $79,538.68-$118,661.11 1 day ago

Cambridge, MA $3,000.00-$4,000.00 4 days ago

Framingham, MA $3,000.00-$4,000.00 4 days ago

Senior Information Technology Support EngineerHelp Desk Support Engineer - Onsite Boston MA AreaLead Support Engineer, Corporate IT Operations

Waltham, MA $80,000.00-$110,000.00 1 week ago

Technical Support Engineer, Amazon Robotics Technical Support

Danvers, MA $105,000.00-$120,000.00 1 month ago

Principal Technical Support Engineer (Multiple Openings)

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr