Validation Engineer

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)