*validation engineer ii*
*responsibilities*:
- completes projects as assigned by the department manager.
must be able to prioritize responsibilities and establish timelines in order to maintain a balance of support in all projects and execute projects with clear objectives*.
*:
- generates and revises validation protocols, sops, drawings, equipment specifications, engineering test reports (etr) and technical reports.
- proficiently develops and performs testing and evaluation of process validations and software validations in compliance with all installation qualifications (iq), operational qualifications (oq), and performance qualification (pq).
documents all activities appropriately.
- evaluates and executes validation/requalification.
- maintains and assists in establishing standardized methods and procedures for software, process, and test method validations and ensure standardized methods are implemented and followed.
- maintain compliance with applicable gmp standards, iso standards, local standard operating procedures (sop)'s and company policies.
maintain a safe work environment for self and other employees.
- works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors.
exercises judgment within defined procedures and practices to determine appropriate action.
*qualifications*:
- bachelor's degree required, preferably in mechanical, electrical, electromechanical, or biomedical engineering.
- minimum 2 - 5 years of related experience; or an advanced degree without experience.
- bilingual (english/spanish).
- good working knowledge of production processes, sops, drawings, machine specifications, and required test equipment/fixtures.
- ability to read, analyze, and interpret common scientific and technical reports, technical procedures, validation protocols and reports, operating instructions and regulations.
- ability to write reports, business correspondence, and procedures.
must be able to prepare clear and informative engineering and technical reports with accuracy.
- ability to work with mathematical concepts such as probability, statistical inference, and fundamentals of plain and solid geometry and trigonometry on a scientific level.
- ability to define problems, collects data, establish facts, and draw valid conclusions.
- ability to effectively present information to upper management and other groups.
- capable of working independently and is self-motivated to improve skill set related to recognized process validation techniques.
- effective in written and verbal communications.
- good understanding of software management tools, spreadsheets, and word processing software.
- understanding of relationship between medical device manufacturer and regulatory agencies which monitor them.
- u.s.a visa required.
- availability to travel to the u.s. and other country if required.