Senior Validation Engineer

Summary

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.

Responsibilities

• Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
• Work with project teams to develop the commissioning and qualification strategy and document in qualification plans.
• Generate/evaluate qualification/validation protocols including IQ, OQ, FT, PQ protocols and final reports for new or modified GMP analytical and process equipment, utilities, and facilities.
• Execute IQ, OQ, FT, PQ protocols, which may involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP analytical and process equipment, utilities, and facilities.
• Ensure that Qualification/Validation plans are generated and updated for all ongoing projects.
• Prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, qualification/validation documentation.
• Develop and/or execute FAT/SAT and other commissioning activities for new GMP systems in collaboration with both internal and external partners.
• May include conducting validation maintenance activities including performing and scheduling periodic reviews.
• Other duties may be assigned to this role.

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.

Education

• Doctorate degree OR
• Masters degree and 2 years of experience OR
• Bachelors degree and 4 years of experience OR
• Associates degree and 8 years of experience OR
• High school diploma / GED and 10 years of experience