Computer System Validation Engineer

Wunderlich-Malec Engineering (WM) is a 100% employee-owned ESOP and one of the largest and most well-established engineering companies in the United States. When you join WM you become part of a company that is:

• 100% employee-owned with 40 years of industry history
• ENR (Engineering News Record) Top 500 firm
• Rated as a top System Integrator Giant

We have a Computer System Validation Engineer position. The CSV Engineer This position will ensure that all computer systems and software used in manufacturing and laboratory environments comply with regulatory requirements and industry standards. This role involves developing, executing, and maintaining validation protocols and documentation to support the validation lifecycle of GxP systems.

Job Responsibilities:

• Interface with our clients and take responsibility for preparing and executing computer system validation documents for a variety of distributed control, process control, and stand-alone production systems
• Develop documents and execute computer system validation test scripts, including SFATs, HFATs, traceability matrices, IQs, and OQs
• Ensure all validation activities comply with relevant regulations and industry standards, such as GxP, FDA, or ISO requirements
• Interface directly with clients to understand their needs and ensure project requirements are met
• Assist with design, development, and implementation of Manufacturing Execution System (MES) solutions

Job Requirements

Education A Bachelor of Science degree in Engineering, Computer Science, or related technical field

Experience 4 years with capabilities in the below areas is preferred:

• Computer system validation experience in the pharmaceutical, biotech, medical device or other FDA-regulated industries
• Competency with FDA Data Integrity requirements and exposure to data integrity risk and gap assessments
• A solid understanding of GAMP and 21 CFR Part 11 requirements
• Experience in generating software development life cycle documentation such as FRSs, SDSs, HDSs, and configuration specifications
• MES solution deployment experience with but not limited to PAS-X, Syncade, Apprentice or POMS
• Hands-on experience with but not limited to Emerson DeltaV, Allen Bradley PLC, Wonderware, OSI PI, Ignition or Rockwell software platform
• An understanding of laboratory systems and CSV for process control systems for clean utilities and bioprocess manufacturing equipment
• A willingness to design, develop, document, test, and implement Manufacturing Execution Systems (MES) within life sciences (biopharmaceutical) environments. Experience preferred
• Strong communication and interpersonal skills to work effectively with clients and team members
• Self-motivated, proactive, and capable of working in a project-based consulting role
• Ability to travel up to 25%

Physical Demand of Position Seeing, color perception, hearing, clear speech, dexterity in hands, driving, lifting, ability to mount/dismount equipment, pushing and pulling.

Working Conditions Standard office environment, on-site office environment, diverse industrial environments, frequent use of a personal computer, facsimile/copy machines, and phones.

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