Process Engineer II

Join Us in Changing Lives

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful.

Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us.

We’re currently recruiting for a Process Engineer II to join our Engineering team. In this role, you will participate on project teams, assuring that projects are coordinated with team members and compliant with applicable policies/procedures, playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be:

• Support third party firms for equipment detailed design and commissioning and qualification (C&Q).
• Execute engineering change management, quality events (e.g. change control, corrective action/preventative action, etc.), and project close-out documentation.
• In collaboration with Quality Assurance, support the site strategy for equipment requalification and implementation of program.
• Provide engineering technical support to site operations and validation activities (FAT, SAT, commissioning, IQ/OQ/PQ) with creative approaches, as well as adaptation to corporate, site and/or industry standards/methodology.
• Diagnose technical issues and current practices and provides recommendation/solution for their correction.
• Responsible owner for development and maintenance of equipment drawings (P&IDs, PFDs, etc) and utility equipment lifecycle (URSs).
• Provide support identify spare parts for incoming utility systems.
• Ensure potential safety hazards are identified/shared and effective actions are rapidly implemented.
• Embed the highest standards of compliance with our quality systems into the site’s day-to-day activities.

We are looking for:

• BS/MS in Engineering or a related field with 3+ years of experience in a technical engineering role or related areas.
• Minimum 3 years of experience in pharmaceutical/biotech manufacturing, design, or consulting environment, supporting utility design, procurement, qualification, and support.
• Familiar with FDA and EU regulations and GMP standards. First-hand experience with agency filings and inspections is a plus.
• Prior cGMP cell or gene therapy manufacturing experience is highly desired.
• Ability to work in a matrixed-team environment, meet deadlines, and self-prioritize and balance work from multiple individuals and multiple projects.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

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?

• 💸 Competitive total reward packages
• 🧘 Wellbeing programs that support your mental and physical health
• 🚀 Career development opportunities to help you grow and thrive
• 🤝 Supportive, inclusive, and collaborative culture
• 🧪 State-of-the-art labs and manufacturing facilities
• 🌍 A company that lives its values: Responsible, Responsive, Resilient, Respect
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We want you to feel inspired every day. At OXB, we’re future-focused and growing fast. We succeed together—through passion, commitment, and teamwork.

Ready to Make a Difference?