Senior Validation Engineer
About The Position
The Senior Validation Engineer leads validation strategy, execution, and continuous improvement for custom automated converting, packaging, and coating equipment. The role provides advanced technical expertise in validation methodologies, mentors team members, and ensures compliance with industry standards and customer requirements. It partners across functions to drive quality, efficiency, and innovation across projects. This is a full-time, exempt, on-site position in a primarily office environment, with periods spent in the machine assembly environment testing equipment. Core office hours are Monday through Friday, 9:00 a.m. to 3:30 p.m. Travel may be required based on project or customer needs. The salary range is $110,000–$130,000 per year, depending on experience.
Requirements
- Bachelor’s degree in engineering or another 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.
- Strong leadership and mentoring capability.
- Advanced technical expertise in validation methodologies and regulatory requirements.
- Customer/client focus and ability to lead technical discussions.
- Proficiency with Microsoft Office products.
- 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 and schematic interpretation skills.
- High attention to detail with a focus on quality and compliance.
- Ability to meet the stated physical demands, including frequent lifting or moving of objects up to 25 pounds.
Nice To Haves
- Experience working in regulated environments, such as medical device, pharmaceutical, or similar industries.
- Experience with Adobe Creative Suite and FrameMaker.
Responsibilities
- Lead development and execution of validation strategies and test protocols, and prepare comprehensive technical reports aligned with customer deliverables and project schedules.
- Serve as the technical expert for 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, including FMEA, FDS, SDS, IQ, OQ, PQ, and related deliverables.
- Coordinate validation activities across engineering, manufacturing, and quality teams to meet project timelines.
- Conduct risk assessments and guide mitigation strategies.
- Evaluate and approve impact assessments for changes to validated systems and lead revalidation as required.
- Support customer technical discussions, audits, and documentation reviews.
- Identify opportunities to improve validation processes, tools, and standards, and lead implementation of best practices.
- Mentor and guide Validation Engineers and cross-functional team members.
- Model and steward Delta ModTech’s values: Believe in People, Fearless Innovation, Integrity, Passionate & Tenacious, and Servant Leadership.
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) match
- Paid Time Off (PTO)
- Discretionary bonus
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What This Job Offers
Job Type
Full-time
Career Level
Senior
