Senior Validation Engineer I at Ultragenyx in Bedford, MA

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
Validation experience using risk-based approach (FMEA, PHA, etc)
Experience with investigations into deviations and determination of product impact potential, root cause, and corrective actions
Travel between Ultragenyx sites in Massachusetts is required

Physical Demand Requirements

Stand for extended periods of time with periodic stooping / bending / kneeling

Able to lift, push, pull up to 50lbs

Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment

Working in temperature-controlled environments (cold rooms)

#LI-CK1 #LI-Onsite
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range$119,300—$147,300 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * Benefits vary by region and country
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
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