Senior Validation Engineer — cGMP & QA Leadership

PROMED MOLDED PRODUCTS INC; Plymouth (MN); On-site; USD 94,000 - 130,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account/Flex Spending

Vision Insurance

Life Insurance

Paid Family Medical Leave and Long‑The

Long-Term Disability Insurance

Hospital Indemnity, Critical Illness,

Pet Insurance

Job summary

PROMED MOLDED PRODUCTS INC in Minnesota is seeking a Senior Validation Engineer to oversee qualification and validation of equipment, utilities, and processes in a cGMP environment. You will own VMPs, risk-based strategies, and regulatory alignment across FDA/EMA expectations.

The role requires hands-on validation execution, strong writing and cross-functional leadership, and the ability to manage multiple concurrent client programs while mentoring junior engineers.

Qualifications

• Deep knowledge of cGMP requirements and FDA/EMA expectations for process validation.
• Hands-on experience authoring and executing validation studies in a regulated manufacturing environment.
• Experience developing cleaning validation programs, including toxicological limit-setting and analytical sampling methods.
• Strong statistical and data analysis skills to support validation acceptance criteria.

Responsibilities

• 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 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 PQ/PPQ protocols for manufacturing processes.
• Develop and execute cleaning validation protocols with worst-case product considerations and sampling plans.
• Collaborate with Process Development and Manufacturing to define CPPs and CQAs.
• Analyze validation data and author final summary reports with statistically sound conclusions.
• Support CPV programs to maintain the validated state throughout the product lifecycle.
• Serve as validation SME for client-facing discussions, audits, and regulatory inspections.
• Lead or support investigations into validation-related deviations and CAPA development.
• Mentor junior validation engineers and provide technical guidance on protocol authorship and reporting.
• Present validation strategies, progress, and results to client stakeholders and internal governance teams.

Skills

cGMP knowledge

Process validation

Statistical analysis

Technical writing

Cross-functional collaboration

Education

Bachelor's degree

Job description

PROMED MOLDED PRODUCTS INC in Minnesota is seeking a Senior Validation Engineer to oversee qualification and validation of equipment, utilities, and processes in a cGMP environment. You will own VMPs, risk-based strategies, and regulatory alignment across FDA/EMA expectations.

The role requires hands-on validation execution, strong writing and cross-functional leadership, and the ability to manage multiple concurrent client programs while mentoring junior engineers.