Validation Engineer

Validation Engineer II

The Validation Engineer II will support validation activities for GMP manufacturing facilities, utilities, equipment, laboratory systems, and processes within a regulated environment. The role is responsible for developing validation strategies, authoring lifecycle documentation, executing qualification protocols, and maintaining compliance with quality and regulatory requirements. This position works closely with cross-functional teams to ensure systems and processes remain in a validated state throughout their lifecycle.

Key Responsibilities:

• Develop and execute validation strategies for GMP facilities, utilities, process equipment, laboratory systems, and analytical instruments
• Author and execute Validation Master Plans, qualification plans, and validation protocols using risk-based methodologies
• Develop and review User Requirements Specifications, functional requirements, risk assessments, and Requirements Traceability Matrices
• Create and execute Installation Qualification, Operational Qualification, and Performance Qualification protocols
• Lead or support process validation, engineering studies, test method validation, and equipment qualification activities
• Manage validation protocol execution to ensure timely completion and compliance with regulatory requirements
• Evaluate validation results, investigate deviations, and prepare validation reports and corrective action documentation
• Support commissioning, installation verification, startup activities, and transfer of systems into GMP operations
• Review change control documentation and assess validation impact for process, equipment, and system changes
• Track validation project progress and provide status updates to stakeholders
• Collaborate with equipment vendors and internal teams during qualification and commissioning activities
• Participate in internal and external audits and present validation status and recommendations during project reviews
• Provide technical guidance and mentorship to less experienced team members

Required Qualifications:

• Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Quality, or a related field
• Minimum 2 years of experience in validation, qualification, engineering, or quality within a regulated environment
• Experience developing and executing validation lifecycle documentation including Validation Master Plans, User Requirements Specifications, risk assessments, and Requirements Traceability Matrices
• Experience executing Installation Qualification, Operational Qualification, and Performance Qualification activities
• Knowledge of GMP regulations, quality systems, and validation principles
• Experience supporting change control, deviation investigations, and corrective action activities
• Strong technical writing, analytical, and problem-solving skills
• Ability to work effectively within cross-functional teams and manage multiple priorities

Preferred Qualifications:

• Master's Degree in a related field
• Experience validating GMP manufacturing equipment used in biotechnology, biologics, pharmaceutical, or oligonucleotide manufacturing environments
• Hands-on experience with analytical instrumentation including HPLC systems, chromatography data systems, and spectrophotometers
• Experience with automated purification systems, tangential flow filtration, and chromatography platforms
• Knowledge of commissioning and qualification activities for manufacturing facilities, clean rooms, laboratories, and utilities
• Experience collaborating with equipment vendors and reviewing vendor qualification documentation
• Experience supporting full validation lifecycle activities from commissioning through ongoing validated-state maintenance

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $30/hr to $40/hr