Lead Validation Engineer – Medical Devices & Packaging

hiring and management practices that empower individuals, who are open to change and growth in their; Ramsey (MN); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Short-Term Disability

Long-Term Disability

Flexible Spending Account (FSA)

Life Insurance

Health Savings Account (HSA) with up 0

Job summary

Delta ModTech is seeking a Senior Validation Engineer to lead validation strategy for custom automated converting, packaging, and coating equipment. You will mentor teammates and ensure compliance with industry standards while coordinating across engineering, manufacturing, and quality teams.

Core responsibilities include developing validation plans, executing test protocols, reviewing documentation (FMEA, IQ/OQ/PQ), and driving continuous improvement.

Qualifications

• Bachelor's degree in engineering or other relevant technical discipline.
• 7+ years of experience validating manufacturing equipment and/or software.
• Experience leading validation efforts and influencing cross-functional teams.
• Experience in regulated environments preferred (medical device/pharma).

Responsibilities

• Lead development and execution of validation strategies, test protocols, and reports.
• Serve as technical expert for equipment, systems, and process validation.
• Oversee monitoring, sampling, and testing to meet specs.
• Author/review/approve validation docs: FMEA, FDS, SDS, IQ/OQ/PQ, etc.
• Coordinate validation activities across engineering, manufacturing and quality.
• Conduct risk assessments and mitigation guidance for validation outcomes.
• Approve changes to validated systems and lead revalidation.
• Support customer interactions, audits, and documentation reviews.
• Identify and implement improvements to validation processes/tools.

Skills

Leadership

Validation methodologies

Regulatory requirements

Customer focus

Analytical skills

Project management

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Tools

MS Office

Adobe Creative Suite

FrameMaker

Job description

Delta ModTech is seeking a Senior Validation Engineer to lead validation strategy for custom automated converting, packaging, and coating equipment. You will mentor teammates and ensure compliance with industry standards while coordinating across engineering, manufacturing, and quality teams.

Core responsibilities include developing validation plans, executing test protocols, reviewing documentation (FMEA, IQ/OQ/PQ), and driving continuous improvement.