Validation Engineer

About the role

The 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 and can author and execute protocols, support field activities, resolve deviations, evaluate data, and complete final reports.

Responsibilities

• Support validation projects from planning through execution, final reporting, and closeout activities.
• Author, review, and execute validation documentation including URS, risk assessments, FAT, SAT, IQ, OQ, PQ, traceability matrices, and summary reports.
• Assist in development and revision of SOPs, Validation Master Plans (VMPs), work instructions, and quality system documentation.
• Maintain accurate and complete validation records in accordance with document control and data integrity requirements.
• Participate in project planning, scheduling, and resource coordination to ensure validation deliverables are completed on time.
• Support qualification and validation of manufacturing equipment, process systems, utilities, cleanrooms, facilities, laboratory instruments, automation systems, and cleaning processes.
• Perform equipment walkdowns, commissioning support, startup activities, requalification, periodic reviews, and lifecycle management activities.
• Review technical drawings, P&IDs, specifications, calibration records, maintenance records, and vendor documentation to support qualification activities.
• Support technology transfers, facility expansions, equipment upgrades, and remediation projects.
• Support process validation protocol execution, continued process verification (CPV), and process performance monitoring.
• Collect, analyze, and trend validation data to ensure compliance with approved acceptance criteria and regulatory requirements.
• Assist with new product introductions and validation activities associated with process changes and improvements.
• Assist with cleaning validation strategies, master plans, protocols, sampling plans, execution activities, and final reports.
• Support surface area calculations, worst-case product selection, swab and rinse sampling, recovery studies, hold-time studies, residue limit calculations, and CIP, COP, and manual cleaning validation activities.
• Evaluate and document cleaning effectiveness to ensure product quality and regulatory compliance.
• Document, investigate, and support resolution of deviations, CAPAs, investigations, nonconformances, and change controls.
• Ensure compliance with cGMP, FDA, EMA, ICH, ISPE, and company quality standards.
• Support internal audits, client audits, regulatory inspections, and responses to audit observations.
• Participate in continuous improvement initiatives focused on compliance, quality, efficiency, and inspection readiness.
• Coordinate validation activities with Engineering, Manufacturing, MS&T, QA, QC, Maintenance, Facilities, Automation, and external vendors.
• Provide technical support and training to internal teams regarding validation requirements, documentation practices, and regulatory expectations.
• Facilitate consultant-to-internal staff knowledge transfer to ensure long-term sustainability of validation programs and processes.
• Collaborate with cross-functional stakeholders to identify and resolve technical and compliance issues throughout the validation lifecycle.

Required Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related technical field required.
• 3 to 5 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.
• Strong understanding of cGMP requirements and risk-based approaches to validation and lifecycle management.
• Ability to effectively collaborate with Manufacturing, Engineering, Quality Assurance, Quality Control, and Regulatory Affairs teams in a fast-paced regulated environment.

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.

Pay & Benefits

The salary range for this position is $90,000 to $115,000, 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.