Validation Engineer II

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 II, you will be responsible to interact with multiple departments to provide commissioning, qualification, and validation support for equipment and computer systems, along with the critical utilities and facilities required for site technical operations. You will be responsible to ensure site compliance and all necessary activities are performed on time to keep all equipment and systems in a validated state.

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.

Main Responsibilities:

• Development of user requirements, functional requirements, design requirements, trace matrices, test protocols for installation, operation, performance of equipment, risk assessments, cleaning validation protocols/reports, sterilization validation protocols/reports, airflow visualization protocols/reports, computer system validation protocols/reports, commissioning summary reports and validation summary reports.
• Execute IQ/OQ/PQ protocols, computer system validation protocols, cleaning development and/or validation, sterilization development and/or validation and other cycle development and validation protocols as needed.
• Conduct all work according to governing policies, Validation Master Plans, SOPs, industry standards, and governing regulations / cGMPs.
• Analyze validation test data to determine whether equipment and systems have met validation acceptance criteria.
• Assist in the identification of potential root causes of technical issues during commissioning and qualification.
• Identify protocol discrepancies from established product or process standards and provide recommendations for resolving protocol discrepancies.
• Support maintenance of the validation program, including execution of requalification activities and revisions to commissioning and qualification standard operating procedures (SOPs).
• Provide constant communications with all affected departments and personnel regarding validation activities.
• Conduct all activities in a safe and efficient manner.
• Other duties may be assigned to meet business needs.

What you’ll bring:

• Bachelors degree in Life Science, Engineering or related field and 2+ years of validation experience in a regulated industry
• Experience with computer systems validation
• Good understanding of cGMP and GDP
• Effective time management and prioritization skills
• Ability to work in a fast-paced environment with multi-tasks
• 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 Power Point