Validation Engineer III

We are seeking a motivated and skilled individual who is passionate about the future of science. If you are eager to contribute to our vision and make a meaningful impact, we encourage you to apply.  As a Validation Engineer III, you will be responsible for equipment, computer system, and facility qualification projects and the execution of commissioning and validation documents for equipment and systems in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs.

About Ascend: 

Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products.

Our goal is to inspire the next generation of experts and breakthrough start-ups in the gene and cell therapy field. With a startup mindset and a track record of rapid growth, we aim to exceed boundaries and achieve continued success. Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve.

Requirements

• Author validation plans; assist with the development of specification for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, IQ/OQ/PQ, cleaning validation, sterilization validation, airflow visualization and computer system validation.
• Review and approve commissioning, qualification and validation related system lifecycle documentation and design specifications, commissioning and qualification protocols.
• Provide leadership and expertise for validation activities during the tech transfer of new products in the manufacturing facility
• Provide leadership and expertise for the CQV revalidation program for the site
• Perform validation assessments associated with equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment
• Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment and facilities
• Conduct all work according to governing SOPs and cGMPs
• Analyze validation test data to determine whether equipment and systems have met validation acceptance criteria or to identify root causes of problems
• Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols
• Provide constant communications with all affected departments and personnel regarding validation activities
• Other duties may be assigned to meet business needs.

What you’ll bring:

• Bachelors degree in Life Science, Engineering or related field and 5+ years of validation experience in a regulated industry
• Experience with Data Integrity Principles as part of standard work preferred
• Experience with computer systems validation
• Good understanding of cGMP and GDP
• Highly motivated with the ability to work independently and in a team
• Detail oriented with strong written and verbal communication skills
• Working knowledge of Microsoft Word, Excel and PowerPoint

Benefits

• Annual bonus
• 401k matching up to 3%, 50% on the next 2%
• Medical, Dental, Vision, Life, Short-Term and Long-Term Disability, AD&D, and additional insurances.
• 20 days PTO
• 5 days Sick leave
• 6 weeks Parental Leave

Company Values:

Aim Higher – Our motto and values. 

Quality by integrity - We set high standards, putting quality and evidence first to seek the best solutions.

Adaptability is in our DNA - We are forward-thinking problem solvers, driven by the developing science and to deliver the best medicines.

Serving patients by serving our partners - We can depend on each other, and on the organisation, to deliver goals and services.

To start your journey with us at Ascend, kindly submit your resume and a cover letter showcasing your qualifications and interest in the role. We value diversity and oppose discrimination. While we eagerly await all applications, we'll only reach out to selected candidates for interviews. Please note that successful candidates must be legally authorized to work in the United States and will undergo E-verify authentication. Thank you for considering joining our team as we shape the future together!