Senior Validation Engineer

The Senior Validation Engineer will support commissioning, qualification, process validation, cleaning validation, and validation lifecycle activities at the Phlow Petersburg Campus. This role requires a flexible, hands‑on validation professional who can independently develop strategies, author and execute protocols, support field activities, resolve deviations, evaluate data, and complete final reports.

• Lead validation projects through the full validation lifecycle, including planning, execution, reporting, and closeout activities, ensuring projects are completed on time and in compliance with applicable regulatory and quality standards.
• Develop project plans, schedules, and resource requirements while providing regular updates to stakeholders and management.

• Author, review, and execute commissioning and qualification documentation, including User Requirements Specifications (URS), risk assessments, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support qualification activities for manufacturing equipment, facilities, utilities, laboratory systems, automation platforms, and cleaning systems.
• Conduct equipment walkdowns, startup support, operational readiness reviews, requalification activities, and periodic reviews to maintain validated system status.

• Develop, execute, and report on process validation protocols, including Process Performance Qualification (PPQ) and Continued Process Verification (CPV).
• Analyze validation data, identify trends, and ensure manufacturing processes consistently operate within validated parameters.

• Develop cleaning validation strategies, protocols, sampling plans, risk assessments, and final reports.
• Support establishment of HBEL/PDE- and MACO-based cleaning limits and perform worst‑case product assessments.
• Execute and evaluate swab and rinse recovery studies, hold‑time studies, and CIP, COP, and manual cleaning validation activities.

• Assess deviations, investigations, CAPAs, change controls, and equipment modifications to determine validation impact and ensure appropriate documentation and compliance.
• Ensure all validation activities are conducted in accordance with cGMP requirements, FDA regulations, internal procedures, and industry best practices.
• Support regulatory inspections, customer audits, and internal audits by maintaining inspection‑ready documentation and records.

• Prepare, review, and maintain validation protocols, reports, risk assessments, traceability matrices, SOPs, and other validation‑related documentation.
• Ensure documentation is accurate, complete, and compliant with data integrity and document control requirements.

• Partner with Engineering, Manufacturing, MS&T, Quality Assurance, Quality Control, Maintenance, Facilities, Automation, and external vendors to coordinate validation activities and resolve technical issues.
• Provide technical guidance and support to project teams regarding validation requirements, regulatory expectations, and industry standards.

• Identify opportunities to enhance validation processes, procedures, and systems through risk‑based approaches and operational excellence initiatives.
• Support knowledge transfer, training, and implementation of best practices to strengthen validation programs and organizational capabilities.

The salary range for this position is $120,000 to $150,000, with the final offer determined based on factors such as the candidate's experience, qualifications, skills, and education. In addition to a competitive base salary, this position is eligible to participate in Phlow's bonus and stock option programs. Phlow also offers a comprehensive benefits package that includes medical, life, and disability insurance;

retirement savings plans; paid time off and company holidays; and education‑related benefits. Many of these programs are fully funded or significantly subsidized by…