Senior C&Q Validation Engineer – GMP Analytical & Process Equipment- (JP15147)
About The Position
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 include: 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. Why is the Position Open? Supplement additional workload on team
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.
- Experience in commissioning/qualification/validation
- Experience in a GMP environment
- Experience with analytical instruments (Benchtop laboratory equipment)
- 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
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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Career Level
Mid Level
Education Level
High school or GED
Number of Employees
1-10 employees
