Senior Validation Engineer: Lead PQ/PPQ & Validation

Socket.dev; Plymouth (MN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account

Dental Insurance

Vision Insurance

Life Insurance

Paid Family Medical Leave

Hospital Indemnity

Critical Illness

Accident

Identity Theft Protection

Pet Insurance

Job summary

ProMed in Minnesota seeks a Senior Validation Engineer to ensure our facility, equipment, and processes stay in control and compliant with cGMP and regulatory expectations. You will lead validation strategies, PQ/PPQ execution, and cross-functional collaboration with QA, Process Development, and Manufacturing across multiple client programs.

The role demands strong technical writing, data analysis, and the ability to mentor junior engineers while guiding audits and inspections.

Qualifications

• 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.
• Working knowledge of statistical tools used in validation and continued process verification.
• Experience supporting regulatory inspections or client audits related to validation activities.

Responsibilities

• Author and maintain Validation Master Plans 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 PQ and 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 CPPs and 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.
• Serve as validation 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.

Skills

cGMP knowledge

Validation studies

Cleaning validation

Statistical analysis

Project management

Technical writing

Cross-functional communication

Education

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

Tools

Statistical tools

Job description

ProMed in Minnesota seeks a Senior Validation Engineer to ensure our facility, equipment, and processes stay in control and compliant with cGMP and regulatory expectations. You will lead validation strategies, PQ/PPQ execution, and cross-functional collaboration with QA, Process Development, and Manufacturing across multiple client programs.

The role demands strong technical writing, data analysis, and the ability to mentor junior engineers while guiding audits and inspections.