Validation Engineer III

About the role

We are currently recruiting for a Validation Engineer III to join our Engineering Team. This role supports Engineering, Manufacturing, Quality Control, and Facilities teams by executing initial validation and qualification of equipment, utilities, facilities, and systems, as well as implementing the requalification and periodic review program. You will play a key role in advancing our mission and making a meaningful difference.

Responsibilities

• Write, execute, summarize and lead validation activities for: Analytical instruments, Computer Systems (as applicable to complex instruments and manufacturing equipment), Equipment, Utilities, and Facilities.
• Develop Validation Plans and Validation Plan Summary Reports.
• Develop, review, and provide guidance on internal validation documents.
• Develop, support, and assess CAPAs, Change Controls, Deviations, Investigations and Risk Management as they pertain to validation.
• Provide technical input to strategy/philosophy for validation activities.
• Represent validation during tech transfer activities.
• Front facing during agency inspections, client audits representing the validation function.
• Lead and manage complex validation and technical projects.
• Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations, including being on-call for after-hours remote support.

Requirements

• A minimum of bachelor’s degree in science, engineering or related discipline.
• Minimum of 5+ years of experience in the execution of validation studies in a regulated manufacturing environment.
• Thorough knowledge and understanding of FDA and international health authority expectations.
• Experience in authoring and review/approval of CQV documentation including validation plans, protocols, reports, trace matrices and SOPs.

Qualifications

• Strong problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.

Skills

• Knowledge of GMP regulations and guidelines.
• Experience with validation software tools.
• Strong organizational and project management skills.
• Ability to work in a fast-paced, dynamic environment.

Benefits

At OXB, we offer competitive total reward packages, wellbeing programs that support your mental and physical health, career development opportunities, and a supportive, inclusive, and collaborative culture.

Pay

Competitive total reward packages.

Schedule

Full time, On-site.

About Us

OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 30 years of experience in viral vectors; the driving force behind the majority of gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

Why Join Us?

• Future-focused and growing fast.
• Supportive, inclusive, and collaborative culture.
• State-of-the-art labs and manufacturing facilities.
• Company that lives its values: Responsible, Responsive, Resilient, Respect.

Nearest Major Market

Durham

Nearest Secondary Market

Raleigh