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OXB · 1 day ago

Process Engineer I

Durham, NC

Full-time

Onsite

New Grad, Entry Level

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. 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.

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 manufacturingCGMP complianceFDA regulationsEU regulationsEngineering degreeTeam collaborationProblem-solving

Required

BS/MS in Engineering or a related field

Willingness to take on other tasks as needed to support site, engineering, and facilities objectives

Must be willing to have a flexible schedule to support 24x7 manufacturing activities

Preferred

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

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