Senior Validation Engineer

Salary Range: $94,373.91 To $ Annually

As a Pro Med employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

Pro Med was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

The mission of the Senior Engineer, Validation is to ensure that our facility, equipment, utilities, and manufacturing processes consistently perform as intended and remain in a state of control that satisfies cGMP and regulatory expectations. This role owns the technical rigor behind qualification and validation activities that give our clients and regulators confidence in every batch we produce.

The position requires deep technical expertise in process validation, strong document authorship and review skills, and the ability to lead validation activities across multiple concurrent client programs in a fast-paced CDMO environment.

The Senior Validation Engineer supports Pro Med’s mission and values by applying and reinforcing the company’s brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work.

While the ways that you fulfill these responsibilities will likely evolve, your core responsibilities are:

On average, this will represent about 30% of your time. In this aspect of your position, we will expect you to:

• Author and maintain site and project-level Validation Master Plans (VMPs) defining scope, strategy, and lifecycle approach for equipment, utilities, and process validation.
• Develop risk-based validation strategies that align with regulatory expectations (FDA, EMA, ICH Q7/Q8/Q9/Q10) and client requirements.
• Establish and maintain validation policies, SOPs, and templates to support consistent execution across programs.
• Partner with Quality Assurance to ensure validation approaches are appropriately risk-assessed and documented.

On average, this will represent about 45% of your time. In this aspect of your position, we will expect you to:

• Author and execute Performance Qualification (PQ) and Process Performance Qualification (PPQ) protocols for manufacturing processes transferring from development to commercial-scale production.
• Develop and execute cleaning validation protocols, including selection of worst-case products, swab/rinse sampling plans, and acceptance criteria based on toxicological limits (e.g., PDE/ADE).
• Collaborate with Process Development and Manufacturing to define critical process parameters (CPPs) and critical quality attributes (CQAs) supporting validation acceptance criteria.
• Analyze validation data and author final summary reports with statistically sound conclusions supporting process and cleaning validation status.
• Support continued process verification (CPV) programs to maintain the validated state throughout the product lifecycle.

On average, this will represent about 25% of your time. In this aspect of your position, we will expect you to:

• Serve as validation subject matter expert (SME) for client-facing technical discussions, audits, and regulatory inspections.
• Lead or support investigations into validation-related deviations, ensuring timely and technically sound root cause analysis and CAPA development.
• Mentor junior validation engineers and provide technical guidance on protocol authorship, execution, and reporting.
• Present validation strategies, progress, and results to client stakeholders and internal governance teams.

• Deep knowledge of cGMP requirements and FDA/EMA expectations for process validation.
• Hands-on experience authoring and executing validation studies a regulated…