Senior Validation Engineer

Full-time, on-site position. Core office hours are Monday through Friday, 9:00 a.m. to 3:30 p.m.

About the role

The Senior Validation Engineer is responsible for leading validation strategy, execution, and continuous improvement efforts for custom automated converting, packaging, and coating equipment. This role provides advanced technical expertise in validation methodologies, mentors team members, and ensures compliance with industry standards and customer requirements. The Senior Validation Engineer partners cross-functionally to drive quality, efficiency, and innovation across projects.

Responsibilities

• Lead the development and execution of validation strategies, test protocols, and comprehensive technical reports while ensuring high-value customer deliverables and alignment with project schedules.
• Serve as the technical expert for validation activities, including equipment, systems, and process validation.
• Oversee and perform monitoring, sampling, and testing to ensure compliance with validation protocols and customer specifications.
• Author, review, and approve validation documentation such as FMEA, FDS, SDS, IQ, OQ, PQ, and related deliverables.
• Provide leadership and direction in coordinating validation activities across engineering, manufacturing, and quality teams to meet project timelines.
• Conduct risk assessments and provide guidance on mitigation strategies to ensure robust validation outcomes.
• Evaluate and approve impact assessments for changes to validated systems and lead revalidation activities as required.
• Support customer interactions, including technical discussions, audits, and documentation reviews.
• Identify opportunities to improve validation processes, tools, and standards, and lead implementation of best practices.
• Mentor and provide guidance to Validation Engineers and cross-functional team members.
• Model, steward, make decisions upon, and expect to be held accountable to Delta ModTech’s values: Believe in People, Fearless Innovation, Integrity, Passionate & Tenacious, Servant Leadership.

Requirements

• 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.

Skills

• Strong leadership and mentoring capability.
• Advanced technical expertise in validation methodologies and regulatory requirements.
• Customer/Client Focus with ability to lead technical discussions.
• Proficiency with Microsoft Office products; experience with Adobe Creative Suite and FrameMaker preferred.
• Strong analytical and problem-solving skills with a risk-based mindset.
• Ability to manage multiple complex projects simultaneously.
• Excellent verbal and written communication skills.
• Working knowledge of mechanical and electrical systems, pneumatics, and hydraulics.
• Advanced blueprint/schematic interpretation skills.
• High attention to detail with a focus on quality and compliance.

Work Environment

• Primarily office environment.
• Periods of time spent in machine assembly environment testing equipment.
• Travel may be required based on project or customer needs.

Physical Demands

• Regularly required to sit.
• Frequently required to walk; use hands to finger, handle or feel; reach with hands and arms; and talk or hear.
• Occasionally required to stand.
• Must frequently lift or move objects up to 25 pounds and occasionally lift or move objects up to 25 pounds.
• Specific vision abilities required include close vision, distance vision, color vision, and the ability to adjust focus.

Pay

$110,000 - $130,000 per year (depending on experience).

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Short-Term Disability
• Long-Term Disability
• Flexible Spending Account (FSA)
• Life Insurance
• Health Savings Account (HSA) with up to $500 annual match (for High Deductible Health Plans)
• 401(k) with match
• Paid Time Off (PTO)
• Discretionary Bonus