Senior Validation Engineer I

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

We are seeking a highly motivated Senior Validation Engineer I, who will be responsible for the generation and execution of validation life cycle documents and data analysis. The validation efforts are primarily focused on the validation of laboratory instruments, utilities, manufacturing (MFG) systems, controlled temperature units, and automation systems. The ideal candidate prepares installation and test validation procedures/protocols to ensure products are manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry practices. Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.

ultrainnovative – Tackle rare and dynamic challenges

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

• Coordination, execution and completion of all aspects of key validation projects  
• Development and execution of project plans, qualification and validation protocols 
• Interfacing and coordinating with other departments, outside contractors, and consultants as necessary to successfully complete validation efforts   
• Analyzing qualifications results, determining acceptability, and generating and resolving protocol discrepancies  
• Generating final reports summarizing results of protocols and project plan execution  
• Routing protocols and reports for review and approval by the appropriate departments   
• Perform periodic system reviews and requalification activities  
• Adhering to procedures that aid in the organization and performance of qualification/validation activities  
• Perform audits and reviews of SOPs and protocols for accuracy, completeness, and correctness. Generate new procedures as needed 
• Assist in study design and master planning activities  
• Assist in preparing for audits and responding to Quality Assurance and regulatory issues
• Lead Validation efforts and teams with responsibility for ensuring project timelines are met
• Other department related duties as assigned 

Requirements:

• A Bachelor’s degree in Engineering, Biological/Physical sciences, or equivalent focus of study from an accredited university or college
• Minimum of 6-8 years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality validation 
• Experience in 3 or more GMP validation disciplines (Process Equipment, Utility (including HVAC), Laboratory, Automation, Computer Systems, Sterilization, Sterile Filling/Isolator or PPQ) with advanced technical knowledge  
• Strong problem-solving and decision-making skills
• Strong understanding of FDA, EMA, and local regulations and guidelines, GAMP, ICH guidelines, and industry best practices