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OXB · 1 day ago

Process Engineer I

Durham, NC, US

Full-time

Onsite

New Grad, Entry Level

OXB is a quality and innovation-led viral vector CDMO focused on enabling life-changing therapies for patients worldwide. They are seeking a Process Engineer to provide operational and equipment support throughout the design and delivery phases, ensuring compliance with safety, regulatory, and quality standards.

BiotechnologyGeneticsTherapeutics

No H1B

Responsibilities

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

Qualification

Pharmaceutical manufacturingGMP standardsFDA regulationsEU regulationsEngineering degreeCGMP experienceTeam collaboration

Required

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

Benefits

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

Company

OXB

OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world.

Founded in 1995