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, cleanrooms, 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.
