Manufacturing Manager Programs – Cleaning Validation

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

Company

hirify.global is a biotechnology company developing treatments and operating an advanced drug substance manufacturing facility with disposable technologies, stainless-steel equipment, industry 4.0 capabilities, and sustainability initiatives.

What you will do

• Lead the team responsible for facility cleaning validation and sterilization programs.
• Provide technical expertise for commissioning, qualification, cleaning and sterilization validation, and validation maintenance.
• Develop and maintain the Validation Master Plan, validation plans, equipment qualification protocols, and reports.
• Coordinate validation activities and project results with Manufacturing, Engineering, Quality, Supply Chain, and Process Development.
• Review and approve cleaning validation documents, including cleaning characterization, inactivation, and acceptance-limit reports.
• Represent validation activities in regulatory filings, audits, inspections, and continuous improvement initiatives.

Requirements

• Doctorate degree; or a master’s degree with 3 years of validation or engineering experience; or a bachelor’s degree with 5 years; or an associate’s degree with 10 years; or a high school diploma/GED with 12 years.
• Experience directly managing people or leading teams, projects, programs, or resource allocation.
• Experience with equipment qualification and cleaning validation in a biologics facility.
• Experience reviewing and approving validation protocols and reports for commissioning, qualification, and change administration.
• Knowledge of EU GMP Annex 15, FDA Title 21 CFR Parts 210 and 211, ASTM E2500, and ICH Q7.
• Ability to provide technical writing, presentations, regulatory submission support, and inspection responses.

Nice to have

• Experience with steaming validation, autoclaves, and controlled temperature chambers.
• Experience managing staff performing technical work safely and compliantly.
• Participation in pre-approval or biennial inspections and observational response plans.

Culture & Benefits

• Career-development resources to expand technical expertise and skills.
• Diverse and inclusive workplace where employees can contribute ideas and take action.
• Health, financial, work-life balance, and career benefits.
• COVID-19 vaccination is required for staff in the United States and Puerto Rico, subject to applicable accommodations.