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Title: Validation Engineer
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: Validation Engineer
- Business Function |Regulatory and Quality
- Position Reports to the Quality Engineering Manager
- Looking for candidates with FDA, GMP experience
- Some documentation required (CAPA)
Compensation, Benefits, and Employment Type
- Duration – Contract – 6 months +
- Pay rate: 50-51/hr.
- Job Location: San Diego, CA
- Job# bh11639
- Date Posted: 8/26/2020
- We are seeking a Validation Engineer III responsible for validation of Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, Cleaning, Supplier, and Shipping as members of Quality Engineering team, ensuring compliance to QMS and applicable standards.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Create, review and approve validation master plans. Author and execute validation protocols and reports (Methods, Equipment, Facilities/Utilities, Raw Materials, Process, Cleaning, Supplier, and Shipping).
- Review the quality and completeness of Change Orders and assess for impact to validations. Review equipment and/or facilities change controls and provide test plans as applicable.
- Lead department and cross-department projects
- Evaluate adequacy of requirements for new or modified processes.
- Lead cross-functional team to conduct and write PFMEAs.
- Support regulatory submissions and supplements notification.
- Participate in process design reviews.
- Propose, plan and execute improvement projects.
- Assist in development, maintenance, and reporting of department metrics.
- Education |Bachelor’s degree in Science or Engineering.
- Experience | Eight to ten years of experience in in-vitro diagnostic, medical device, biotech or pharmaceutical industry.
- Expert in process validation and evaluation criteria.
- Experience with automated production equipment, process, analytical method, facility and utilities qualifications/validations.
- Experience with change control systems.
- Experience with risk management process and documentation
- Experience with PFMEAs.
- Advanced knowledge of statistical principals of DOE, ANOVA, SPC, and sampling plans.
- Advance knowledge of CDRH, CBER and ISO regulations.
- Experience with electronic document management systems.
- Advance knowledge of 21 CFR Part 11.
- Strong computer skills
Ability to multi-task effectively, execute to aggressive timelines
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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