Senior Validation Engineer Lead Strategy and Compliance

Delta ModTech; 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)

401(k) matching

Paid Time Off (PTO)

Discretionary Bonus

Job summary

Delta ModTech is seeking a Senior Validation Engineer to lead validation strategy and execution for custom automated converting, packaging, and coating equipment. You will mentor teams, drive quality, and ensure regulatory compliance across projects.

The role requires 7+ years in validation within regulated environments, strong leadership, and hands-on experience with IQ/OQ/PQ, FMEA, and risk assessments. On-site work with travel as needed is expected.

Qualifications

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

Responsibilities

• Lead validation strategy, execution, and documentation
• Serve as technical expert for validation activities including equipment, systems, and process validation
• Oversee monitoring, sampling, and testing to ensure compliance with validation protocols and specs
• Author, review, and approve validation docs such as FMEA, FDS, SDS, IQ, OQ, PQ
• Coordinate validation activities across engineering, manufacturing, and quality teams to meet timelines
• Conduct risk assessments and provide mitigation guidance for robust validation outcomes
• Lead revalidation as required and approve change impact assessments
• Support customer interactions, audits, and documentation reviews
• Identify and implement improvements to validation processes, tools, and standards
• Mentor Validation Engineers and cross-functional team members

Skills

Leadership

Validation methodologies

Regulatory requirements

Cross-functional leadership

Project management

Written & verbal communication

Education

Bachelor's degree in engineering

7+ years validation experience

Tools

Microsoft Office

FrameMaker

Adobe Creative Suite

Job description

Delta ModTech is seeking a Senior Validation Engineer to lead validation strategy and execution for custom automated converting, packaging, and coating equipment. You will mentor teams, drive quality, and ensure regulatory compliance across projects.

The role requires 7+ years in validation within regulated environments, strong leadership, and hands-on experience with IQ/OQ/PQ, FMEA, and risk assessments. On-site work with travel as needed is expected.