Associate Mfg Systems Engineer I (Biotech)

Location: Holly Springs, North Carolina, United States; onsite work at a manufacturing facility

Company

Biotechnology company developing, manufacturing, and delivering medicines for oncology, inflammation, general medicine, and rare diseases.

What you will do

• Lead the development and implementation of the manufacturing site's validation strategy.
• Develop validation master plans, validation plans, equipment qualification protocols, and reports.
• Support commissioning, qualification, cleaning and sterilization validation, and validation maintenance activities.
• Coordinate validation deliverables with Manufacturing, Engineering, Quality, Supply Chain, and Process Development.
• Support autoclave performance qualification, cleaning validation, controlled temperature chamber validation, and continuous improvement initiatives.

Requirements

• High school diploma/GED with 6 years of Manufacturing or Operations experience, an associate degree with 4 years of experience, or a bachelor's degree.
• Experience or ability to develop expertise in equipment qualification, cleaning validation, sterilization validation, and biologics facility validation strategies.
• Ability to review and approve validation protocols and reports related to facility and equipment commissioning, qualification, and change administration.
• Ability to read P&IDs and manage multiple projects.
• Technical writing and presentation skills for collaboration with technical and senior management staff.

Nice to have

• Experience with Kneat, CDOCs, Laboratory Inventory Management System, and Pi.
• Sample Management lifecycle experience.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program, stock-based long-term incentives, and paid time off.
• Career development opportunities and flexible work models where applicable.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Reasonable accommodations are available for the application and interview process.