$80K — $100K *
The Senior Quality Engineer supports the validations of a designated business unit, including the planning, writing and data analysis for validations. The SQE uses technical writing skills, statistics and other tools to implement products and processes to support production and laboratories. Specifically this role will support process development and manufacturing activities for biological products in a cGMP facility.
1. Plan validation scope for product and process launches.
2. Write protocols and reports demonstrating strong technical writing where background of projects and procedures are clearly presented and conclusions are definitively and clearly stated.
3. Perform data analysis that includes use of statistical tools, trending, ability to perform correlation analysis and other calculations as required.
4. Plan risk management scope for product and process launches.
5. Perform risk assessments independently and as a team applying techniques including FMEA and ALARP.
6. Coordinate with internal and external personnel for standards, data, testing or other activities, as needed.
7. Provide leadership in group regarding validation requirements.
8. Perform other duties as assigned.
MINIMUM JOB REQUIREMENTS
Education: Bachelor of Science in engineering or scientific field
Experience: 5+ years of validation experience in a regulated industry
Skill, and Abilities*:
Basic statistics (ANOVA, t-test)
Fluent in Microsoft Office, specifically Word and Excel
Strong verbal and written communication skills
Work Environment: Office Environment
Occasional Clean Room Access
Be able to life 25 lbs infrequently
Travel up to 20% of the time.
Gowning into a clean room environment when needed
Education: Bachelor’s Degree in Biomedical or Chemical Engineering
Master’s Degree in Engineering or Science
Experience: 7+ years of validation experience in a regulated industry, 5+ years’ practical experience working with a cGMP manufacturing or pharmaceutical products facility.
Skill, and Abilities:
Working knowledge of statistics including the use of statistical software
working knowledge of cell biology, microbiology or other biological
- Good knowledge of GMPs, 21CFR Part 11, Food and Drug Administration (FDA), and other regulatory requirements.
- Has experience with supporting Phase 1, Phase 2 and Phase 3 activities for IND/BLA for biologics.
Valid through: 8/13/2020