Engineering Specialist

Job Description

• Evaluate the impact of validated computerized systems on existing work instructions and processes.
• Prepare and execute computer system validation protocols and generate comprehensive reports.
• Develop and maintain Installation Qualification (IQ) documentation.
• Collaborate with process owners to implement changes to work instructions and ensure compliance.
• Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed.
• Ensure adherence to company procedures, quality system regulations, and industry standards.
• Apply technical expertise and knowledge of engineering practices to optimize equipment and manufacturing techniques.
• Organize and track project progress, maintaining detailed documentation and status updates.
• Contribute to cross-functional projects and support milestone completion.
• Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.
• Other duties may be assigned.

Requirements

Minimum 3 years of relevant validation experience with a Bachelor’s degree in Engineering.

Hands-on experience in Process and Computerized Systems Validation .

Background in FDA-regulated industries (medical devices, pharmaceuticals, biotech).

Experience in medical devices or other highly regulated industry .

Familiarity with SDLC processes .

Experience configuring and troubleshooting Windows 10 desktops (nice to have).

Ability to work independently on moderately complex projects and mentor junior team members when needed.

Knowledge & Technical Skills

Must Have

Nice to Have