Senior Validation Engineer

Roche•Tucson, AZ

About The Position

As a Senior Validation Engineer, you will play a key role in maintaining the reliability and compliance of validation and qualification processes. You will lead the development and execution of comprehensive qualification protocols, including IQ, OQ, and PQ, while ensuring adherence to corporate and regulatory standards. In this role, you will oversee all qualification activities, conduct detailed risk assessments, identify areas for improvement, and implement solutions to enhance process efficiency and product quality. Collaborating with cross-functional teams such as Process Engineering and Automation Maintenance Support, you will ensure seamless integration of qualification activities into the overall production process. Your expertise will support internal and external audits, including the preparation of required documentation and data, ensuring continuous compliance with cGMP, industry regulations, and best practices. You will mentor and guide junior team members on qualification tasks and operating procedures, fostering a culture of technical accuracy and continuous improvement. Additionally, you will evaluate new tools, technologies, and best practices to enhance validation processes and make quality decisions independently. This role provides the opportunity to contribute significantly to product integrity and manufacturing efficiency while advancing your career in a dynamic and innovative environment.

Requirements

Bachelor's Degree (required) - Bachelor’s or Master's degree in Chemical Engineering, Mechanical Engineering, or a related field.
Minimum of 4 years of directly relevant work experience or equivalent combination of education and experience, preferably within the medical devices, pharmaceutical, biotechnology or related industry.
Experience operating in a GMP regulated environment, required.
Experience in qualification within the medical device, pharmaceutical, or biotechnology industry is essential, including demonstrated expertise in protocol development, regulatory compliance, and equipment, system, utilities, and facilities qualification.
Well-versed in qualification principles, practices, and tools used in equipment/system, facilities, and utilities qualification.
Basic understanding of the end-to-end production process of assays and reagents, including the formulation, filling, and packaging process.
Advanced technical writing skills to produce reports and documents.
Demonstrated ability to collaborate across multiple functions in a matrix organization to achieve mutual goals.
Excellent project management skills, capable of managing multiple projects simultaneously and ensuring timely completion while demonstrating strong technical skills, independent thinking, and efficient task prioritization with minimal supervision.
Demonstrated mentoring skills, with experience in guiding and developing team members, ability to influence others, and effective communication and presentation skills to convey technical information to diverse audiences.
This position may require wearing and working in personal protective equipment, as well as availability to work extended hours, weekends, and/or holidays.

Nice To Haves

Working knowledge of lean principals and/or Six Sigma methodologies required and Green Belt preferred.

Responsibilities

Generates and maintains detailed qualification documentation (e.g., Design Qualification, SIAs, QPPs, CA/RAs, TMs, Protocol Reports, and Qualification Project Plan Reports) to support the equipment/system lifecycle.
Reviews and approves User Requirements Specifications (URS) and Functional Design Specifications (FDS) to ensure accurate definition of requirements.
Develops, prepares, oversees, and executes IQ, OQ, and PQ protocols for equipment/systems.
Collaborates with cross-functional teams, including Process Engineering, Automation Maintenance Support, Design Transfer Operations, Manufacturing, Quality, Facilities, and SHE, to ensure seamless execution of qualification activities and successful project milestone achievement.
Conducts detailed risk assessments, leads qualification-related projects, mentors and trains junior engineers, and provides guidance on complex qualification issues.
Evaluates and recommends new tools, technologies, and best practices to enhance qualification activities and leverages experience to make quality decisions independently with minimal management input.
Performs other duties as assigned, contributing to the overall success of the team and objectives.
Maintains Right to Operate by ensuring all processes are performed safely.
Identifies and escalates potential hazards, while promptly reporting and investigating safety incidents, hazards, and near misses using safety reporting tools.
Ensures all activities are conducted in strict adherence to current Good Manufacturing Practices (cGMP), FDA regulations, ISO 13485 standards, and Roche (MQMS) standards.
Keeps updated with changes in relevant regulations and ensure the company’s practices remain compliant.
Adhering to 95% or above internal training compliance.
Prepares for and participates in internal and external audits, providing necessary documentation and addressing audit findings.
Assists with NCR investigations, reworks, and corrective actions.
Address and resolve audit findings promptly and effectively in the area of responsibility.
Uses lean principles to identify and eliminate inefficiencies, redundancies, and non-value-added activities within assigned responsibilities.
Applies problem-solving methodologies, such as the Five Whys, Fishbone (Ishikawa) diagrams, to identify root causes, systematically analyze issues, and implement effective corrective actions.
Employ risk assessment tools to make decisions based on facts and leverage insights derived from thorough analysis to minimize risk.
Uses statistical tools and software (e.g., Minitab) to analyze data and generate actionable plans for statistically relevant improvements.
Develops and maintains standardized procedures, documentation, and guidelines for processes.
Collaborates with other departments to identify and eliminate waste in the end to end manufacturing process while ensuring quality remains uncompromised.