Process/Validation Engineer - Contract Astute Medical, Inc.
THIS JOB HAS EXPIRED Process/Validation Engineer - Contract (2 positions available)
Job ID#: 55125
Astute Medical, Inc., a start-up in vitro diagnostic company, is seeking a Process / Validation Engineer to support new product development and product manufacturing. This position is a technical position that will handle multiple projects and tasks throughout multiple phases of the product lifecycle, ranging from product development to product launch and manufacturing. The Quality / Process Engineer will play an active role in the development and execution of manufacturing processes (specifically validation of manufacturing equipment and processes) to ensure products meet Astute Medical?s quality standards / policies and all regulatory requirements. This is a contract position with an expected duration of 6 months.
Partner with R&D and Engineering teams to develop and transfer manufacturing processes to external contract manufacturing organizations. Ensure process development and transfer activities are based on sound quality engineering principles and in compliance with applicable regulations and standards.
Develop and update process development and transfer documentation such as:
o Standard operating procedures, work instructions, and specifications
o QC test plans, acceptance criteria, and reports
o process and equipment validation plans, protocols, and reports
o Design change plans, requests, and reports
o Manufacturing process flowcharts
o Validation Master Plans, validation protocols, and validation reports
Interface with cross-functional teams and external Contract Manufacturing Organizations to support routine product manufacturing. Ensure product manufacturing meet company quality expectations as well as applicable regulations and standards
Interface with cross-functional teams, including Quality, Contract Manufacturing Organizations and Product Development to develop validation testing and acceptance criteria for new manufacturing equipment in accordance to pre-established timelines. Develop and write validation protocols, oversee validation execution, report on validation status, write validation deviations and reports.
Work up to 50 percent of time at contract manufacturing facilities, supporting the following routine production and quality assurance activities:
o Identification and resolution of production and quality system deficiencies
o Review of GMP documents (batch records, forms, protocols, SOPs) to ensure manufacturing steps are appropriately documented, verified, and in compliance with GDP.
o Investigation / troubleshooting of equipment and process failures
Participate in efforts related to making continuous improvements in product quality
o Tracking and review of production metrics
o Implementation of process improvement efforts
Travel: must be willing to travel up to 50 percent of the time
Minimum of 5 years working experience in a process and / or quality engineering role executing equipment and process validations in the medical device industry. Experience within in-vitro diagnostics preferred.
Experience with FDA (QSR), ISO 13485, MDD, and related regulations / standards
Ability to work effectively with cross-functional teams as well as external corporate partners. Experience working with external contract manufacturing organizations preferred.
Detail-oriented. Ability to multi-task effectively.
Proven track record of resolving technical and / or quality-related issues in a timely and effective manner
A thorough understanding of problem-solving and quality improvement tools as well as quality systems. This includes working knowledge and experience with the following:
o Production and Process Controls
o Risk Management
o Change control processes
o Process / Equipment Validation
Bachelor?s degree in chemical sciences, life sciences, engineering, or other relevant discipline.
Please email or fax your resume or curriculum vitae to us at the address below. Be sure to specify job reference ID# 55125 in the subject of the message.
||San Diego, CA |
THIS JOB HAS EXPIRED