ApTask Global Workforce (AGW) is seeking a Validation Engineer Senior with a biopharmaceutical company. This is a 12+ month contract opportunity with our client located in Thousand Oaks, CA. This is a hybrid position. This position could be extended for up to 3 years.Responsibilities: - Lead and/or execute commissioning and qualification activities on new or modified GMP analytical and process equipment, utilities, and facilities
- Generate, review, and execute C&Q protocols, plans, and summary reports
- Work with project teams and SMEs to develop testing strategies
- Participate in project meetings to inform stakeholders on the progress of C&Q activities
- Plan and track implementation of commissioning & qualification actions/documentation versus project timelines
- Generate, evaluate, and approve qualification/validation protocols including IQ, OQ, FT, and PQ
- Execute IQ, OQ, FT, PQ protocols, which may involve protocol discrepancies, investigation, and corrective action activities
- Prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, and qualification/validation documentation
- Develop and/or execute FAT/SAT and other commissioning activities for new GMP systems
Requirements: - Experience level based on education:
- Doctorate degree OR
- Master's degree and 2 years of experience OR
- Bachelor's degree and 4 years of experience OR
- Associate's degree and 8 years of experience OR
- High school diploma / GED and 10 years of experience
- Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV role
- Experience in a GMP environment
- Experience with analytical instruments (Benchtop laboratory equipment)
- Knowledge of cGMP commissioning/qualification/validation practices
- Experience working with cross-functional stakeholders and within project teams on multiple projects in parallel
- Knowledge of quality assurance principles
- Effective verbal and written communication skills
- Able to think analytically with the ability to resolve issues
Desired skills: - Familiarity with Kneat Gx Platform or other digital C&Q systems
Pay range: Up to $ 68.17 per Hour
Only candidates available and ready to work directly as ApTask Global Workforce (AGW) employees will be considered for this position.
If you have the described qualifications and are interested in this exciting opportunity, please apply! ApTask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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