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.

KEY RESPONSIBILITIES

Validation Project Management

• 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.

Qualification & Commissioning

• 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.

Process Validation

• 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.

Cleaning Validation

• 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.

Quality Systems & Compliance

• 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.

Documentation & Technical Writing

• 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.

Cross-Functional Collaboration

• 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.

Continuous Improvement

• 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 the company, reflecting our commitment to supporting the health, well-being, and professional development of our employees.

REQUIRED QUALIFICATIONS: Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related technical field required. 5 – 7 years of validation experience in pharmaceutical, biotechnology, API, or other regulated manufacturing environments. Experience developing, executing, and/or supporting equipment qualification protocols, including IQ, OQ, and PQ activities. Familiarity with process validation and cleaning validation principles and practices. Strong technical writing, documentation, organizational, and communication skills.

Proven ability to work effectively in cross-functional teams and within both manufacturing and office settings. Knowledge of current Good Manufacturing Practices (cGMP), FDA regulations, and industry validation standards preferred.

PREFERRED QUALIFICATIONS: Experience within API, pharmaceutical, biotechnology, or multi-product manufacturing environments. Hands-on experience with process equipment and systems, including reactors, filter dryers, process piping, clean-in-place (CIP) systems, utilities, and manufacturing automation platforms. Working knowledge of Health-Based Exposure Limits (HBEL), Permitted Daily Exposure (PDE), Maximum Allowable Carryover (MACO), swab and rinse recovery studies, HPLC methods, hold-time studies, and cleaning process development. Familiarity with validation and quality systems, including Veeva, DeltaV, periodic review programs, equipment requalification activities, ICH Q9 risk management principles, and FDA process validation guidance.

KEY COMPETENCIES: Proven expertise in equipment, utility, process, cleaning, and computer system validation within cGMP-regulated pharmaceutical and biotechnology environments. Strong knowledge of FDA, EMA, ICH, GAMP 5, and data integrity requirements, with the ability to develop and execute validation protocols, risk assessments, investigations, deviations, CAPAs, and final reports. Demonstrated project management, analytical, and problem-solving skills, with the ability to lead cross-functional teams, manage multiple priorities, and support continuous improvement initiatives. Excellent technical writing, communication, and collaboration skills, with the ability to effectively partner with Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs.

PHYSICAL REQUIREMENTS: Ability to work in both office and manufacturing environments, including routine access to production, laboratory, utility, and warehouse areas. Ability to stand, walk, climb stairs, and perform equipment walkdowns for extended periods. Ability to wear required personal protective equipment (PPE), including safety glasses, hearing protection, respirators, gloves, and protective clothing as required. Ability to lift and carry up to 25 pounds periodically. Ability to work around manufacturing equipment, chemicals, and industrial utilities in compliance with all safety procedures. Ability to bend, stoop, reach, and access equipment in manufacturing and utility areas as needed to support qualification and validation activities