Title: Test Engineer – Supply Chain Engineering
Location: Bothell WA
Duration: 9+ months with possible extension
Ability to assess product and system performance
Demonstrated abilities supporting system and process validation throughout product lifecycle
Project management skills with the ability to work with cross functional teams
Knowledge of tools and processes related to risk management
Experience defining and documenting validation tests, including peer review and maintaining traceability to requirements
Managed, generated and executed protocols for the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of GMP equipment. Performed Gap Analysis and Remediation of GMP quality systems
Performed system validation for 21 CFR Part 11 compliance.
Candidate must have the following:
Demonstrated leadership skills with ability to complete a project, lead a team, and take ownership of issues
Excellent problem solving skills;
Able to complete a project independently or with a team;
Able to organize and prioritize work load under pressure and time constraints;
Able to communicate and interface effectively with other functional groups of the company;
Able to effectively write procedures and reports;
Conscientious about quality of work;
Motivated to learn new things, self-starter, and interested in the AED business.
BS/MS Engineering or strongly-related discipline;
3-5 years of experience in Manufacturing Engineering.
3-5 years of experience with Process Validation, Software Validation, and Equipment Validations.
Very effective in a highly regulated environment;
Please send me your confirmation that no one else has contacted you for this position apart from APN Team.
Please send me your updated copy of resume along with the best number to reach you ASAP.
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560
Direct: 510.870.8798 | Fax: 510.623.5055 | firstname.lastname@example.org