Validation Specialist; Pharmaceutical Industry

Job Description As a Pro Med employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Pro Med was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. 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. 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.

• 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.
• Author and execute Performance Qualification (PQ) and Process Performance Qualification (PPQ) protocols for manufacturing processes transferring from development to commercial-scale production.
• 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.
• 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.
• Hands-on experience authoring and executing validation studies a regulated manufacturing environment.

Strong statistical and data analysis skills to support validation acceptance criteria and continued process verification.

Ability to manage multiple concurrent validation projects across client programs with competing priorities.

Excellent technical writing and cross-functional communication skills.

Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related scientific discipline.

• ~5+ years of experience in validation, equipment qualification, or process engineering within a pharmaceutical, biotechnology, or CDMO environment.
• ~ Demonstrated experience authoring and executing manufacturing process and/or cleaning validation studies.
• ~ Experience supporting regulatory inspections or client audits related to validation activities.

Requires the ability to safely perform the physical movements necessary to carry out the essential functions of the role, including sitting, standing, walking, bending, reaching, lifting, pushing, pulling, and repetitive movements throughout the workday.

Visual acuity for reading technical documents and instrumentation

Tactile sensitivity for equipment and sample handling

Sound judgment under regulatory scrutiny

Adequate coordination/reflexes for equipment operation

Adaptability to shifting priorities

• ~ Health Savings Account/Flexible Spending Account
• ~ Dental Insurance
• ~ Life Insurance
• ~ Paid Family Medical Leave and Long-Term Disability Insurance

Pro Med does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military…