Validation Engineer

The Validation Engineer reports directly to the Manager of Validation.

About the role

This position acts as a Subject Matter Expert (SME) for the Commissioning, Qualification, and Validation (CQV) processes for the site. Responsibilities include commissioning and qualification of equipment, process validation, facilities qualification, utilities qualification, electronic system validation, shipping validation, and program maintenance. The role ensures all systems operate within regulations to produce quality products.

Why join Leiters Health?

• Innovative Culture: Be part of a forward-thinking company that encourages creativity and continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization delivering critical medications and healthcare solutions.
• Professional Development: Access ongoing training, mentorship, and growth opportunities.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies.
• Collaborative Environment: Join a team of passionate individuals dedicated to teamwork and mutual success.

Responsibilities

• Works on projects in a supporting capacity, with communication directed toward the project team, management, or cross-functional groups.
• Works alongside commissioning agents to complete initial facility qualification and bring systems and processes online.
• Utilizes project management skills to plan and coordinate efforts with cross-functional teams.
• Completes tasks in a timely fashion and communicates task status to management or the project team.
• Adheres to GDP/GMP guidelines to author, review, or support technical documents, including change controls and CAPAs.
• Coordinates validation activities with stakeholders.
• Supports writing and executing protocols for validation work.
• Identifies and resolves non-conformances/discrepancies during IQ/OQ/PQ execution and collaborates with cross-functional teams to implement solutions.
• Generates reports, summarizes results, and ensures documents are suitable for regulatory agencies.
• Supports creation or revision of validation templates for protocols and reports.
• Supports creation and review of engineering documentation (URS, FS, SAT, FAT).
• Acts as a subject matter expert for all site qualification and validation activities.
• Supports project work as a specialist on complex technical matters.
• Mentors less experienced team members.
• Performs other duties as assigned.

Requirements

• Bachelor’s degree in a STEM field (e.g., engineering, chemistry) or relevant industry experience.
• 4+ years of validation experience, preferably in a highly regulated environment.
• Experience in project management preferred.
• Demonstrated ability to conduct statistical analysis using software (JMP, MiniTab, SaaS, etc.).
• Strong curiosity, willingness to learn, and tenacity to see projects through.
• Willingness to support tasks outside the normal job description as needed.
• Can-do attitude and ability to create technical and professional documents.
• Strong attention to detail and accuracy.
• Ability to multi-task, with strong organization and time-management skills.
• Ability to work under pressure, independently, and make decisions according to established guidelines.
• Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus.
• Proficient written, verbal, and oral English communication skills.
• Proficiency with Microsoft 365 tools (Outlook, Word, Excel).

Physical Requirements

• Ability to stand or sit for extended periods.
• Ability to lift, push, and pull up to 50 pounds periodically.
• Ability to maintain a gowning qualification and adhere to aseptic practices.

Benefits

• Smart healthcare coverage options that reward wellness.
• Flexible Spending & Health Savings Accounts (FSA & HSA).
• Dental & vision insurance.
• Employer-paid life insurance & employee assistance program.
• Short-term & long-term disability insurance.
• Up to 4% 401K matching (100% vested on day one).
• Generous paid time off options (vacation, sick, paid leave, and holidays).
• $5,250 annual tuition reimbursement after 6 months.
• $1,000 referral bonus program with no limit.
• Eligible for annual bonus program.