OXB
Overview
Join to apply for the
Process Engineer II
role at
OXB . 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 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. Responsibilities
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/preventive 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 provide recommendations/solutions for their correction. Responsible owner for development and maintenance of equipment drawings (P&IDs, PFDs, etc) and utility equipment lifecycle (URSs). Provide support identifying 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 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. Nearest Major Market:
Durham Nearest Secondary Market:
Raleigh
#J-18808-Ljbffr
Join to apply for the
Process Engineer II
role at
OXB . 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 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. Responsibilities
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/preventive 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 provide recommendations/solutions for their correction. Responsible owner for development and maintenance of equipment drawings (P&IDs, PFDs, etc) and utility equipment lifecycle (URSs). Provide support identifying 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 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. Nearest Major Market:
Durham Nearest Secondary Market:
Raleigh
#J-18808-Ljbffr