Title: Validation Engineer Senior
Location: Holly Springs, NC
Duration:12+ Months
Description:
Primarily responsible for leading and/or executing commissioning and qualification activities on new or modified GMP analytical and process equipment, utilities, and facilities. Responsibilities include generating/reviewing/executing C&Q protocols, plans, and summary reports. Works with project teams and SMEs to develop testing strategies. Participates in project meetings to inform stakeholders on progress of C&Q activities.
Key Skills and Requirements:
• Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV role.
• Knowledge of cGMP commissioning/qualification/validation practices.
• Familiarity with Kneat Gx Platform or other digital C&Q systems.
• Experience working with cross-functional stakeholders.
• Knowledge of quality assurance principles.
• Experience working within project teams and multiple projects in parallel.
• Effective communication skills, both verbal and written.
• Able to think analytically with the ability to resolve issues.
• Able to manage own time efficiently.
Top 3 Must Have Skill Sets:
Experience in commissioning/qualification/validation, experience in a GMP environment, experience with analytical instruments (Benchtop laboratory equipment)