The individual will be the Computer System Validation (CSV) lead supporting the Durham, NC site. The CSV Engineer IV will collaborate with global and site stakeholders such as the system owner, process owner, quality, engineering, and manufacturing to develop a highly effective validation program by adopting global standards and processes. The incumbent shall always consi

The Automation Manager will provide strategic guidance for automation and automation related activities with support of day to day operations of the automation for the site along with people leadership. Position Responsibilities Responsible for managing the team that deploys, operates, maintains, and supports onsite process automation systems, equipment and applications.

Participate as a key member of Digital QC system implementation projects, which may include requirements elicitation, technology evaluation, software configuration, customization, testing, validation, support, and end user knowledge transfer. Identify integration points with other systems (e.g., LIMS, LES, and Laboratory Equipment) and understand the technical architectur

Partner with global digital team to lead, manage, direct, and coordinate the activities of the site Digital Operations and Digital Infrastructure teams, and associated quality objectives of the business to meet corporate objectives. Improve site based operations and procedures in alignment with Resilience digital strategy Partner and collaborate with site leadership to im

We seek an experienced Analyst, QC Bioassay / Biochemistry to support establishing new commercial level in house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products. This includes performing analytical methods, data review and trending, and implementation of GMP operational support systems

Analyzing and designing new business processes. Work in partnership with stakeholders to improve the business processes impacted by technology changes, Partner closely with various user communities, fellow team members, technical teams, and vendors to evaluate, design, test, implement, and validate solutions. Identifying and defining detailed product requirements and use