Process Engineer I at oxfordbiom

Durham, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Feb, 26

Salary

0.0

Posted On

17 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Engineering, Pharmaceutical Manufacturing, Biotech Manufacturing, FDA Regulations, EU Regulations, GMP Standards, cGMP, Cell Therapy, Gene Therapy, Safety Compliance, Quality Compliance, Equipment Design, Commissioning, Qualification, Change Control, Preventative Action

Industry

Pharmaceutical Manufacturing

Description

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 to join our Engineering team. In this role, you will provide operational support and equipment support from selection to initial design through delivery and qualification, playing a key part in advancing our mission and making a real difference. Your responsibilities in this role would be: of site projects from inception to completion ensuring safety, regulatory and quality compliance Support equipment and utilities detailed design and commissioning and qualification activities Support department quality events (e.g. change control, corrective action/preventative action, deviations, etc.) Support the development and maintenance of equipment drawings (P&IDs, PFDs, etc) and equipment lifecycle (URSs). Provide support to Facilities/Maintenance team for development of a spare parts program and identify spare parts for incoming equipment. Ensure potential safety hazards are identified/shared and effective actions are rapidly implemented. Must be willing to have a flexible schedule to support 24x7 manufacturing activities. We are looking for: BS/MS in Engineering or a related field Experience in pharmaceutical/biotech manufacturing is a plus Familiar with FDA and EU regulations and GMP standards is a plus Prior cGMP cell or gene therapy manufacturing experience is a plus Willingness to take on other tasks as needed to support site, engineering, and facilities objectives. 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 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?

Responsibilities

The Process Engineer I will provide operational and equipment support from selection to initial design through delivery and qualification. Responsibilities include ensuring safety, regulatory, and quality compliance throughout site projects.