The successful candidate must have Validation experience in regulated environment industries such as pharmaceutical, bio-pharmaceutical or medical devices companies.
The candidate will provide support to the engineering and quality department in the validation of products, equipments or process. Also support pro-field executions and must have availability to work in different shifts.
Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards. Generate new specifications based on new regulations required by the implementation of a new manufacturing process. Generates, executes, reviews, and complete qualification and validation documentation, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Prepares and coordinate qualification activities. Communicate with the staff and management on ways of implementing plans and recommendations.
Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field. Must have solid GMP and regulatory experience with expertise in process validations. Experience in writing and executing validation protocols (i.e. DQ, IQ, OQ, PQ). Experience in writing SOP’s (Standard Operating Procedures). Experience with Technical Writing preferred. Statistical knowledge, DOE and Quality Process Control experience is preferred.
Availability to 2nd shift and 3rd shift, overtime including weekend depending on project requirements. Project Management knowledge. Understanding of statistical analysis and process control. Good problem solving skills. Sense of urgency. Well organized and detail oriented. Availability to travel to job sites when need it. Capable of working with minimum or no supervision. Strong interpersonal skills. Teamwork oriented. Fully Bilingual (English/Spanish) - REQUIRED, oral and writing communication.
Required Related Experience:
2 to 5 years
Minimum Bachelor Degree in Engineering