Validation Engineer

Description

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.

KEY RESPONSIBILITIES

Validation Planning & Documentation

* 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.

Equipment, Facilities & Utility Qualification

* 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.

Process Validation

* 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.

Cleaning Validation

* 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.

Quality Systems & 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.

Cross-Functional Collaboration

* 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.

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.

Requirements

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