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Quality Engineer
2 months ago
A clinical stage biopharmaceutical company on a rapid path to commercialize its proprietary applicator-free, dissolving, microarray patch technology designed to achieve better health outcomes through enhanced therapeutic effects, simplified logistics, and improved patient compliance. Join this team of Scientists and Engineers to make a difference in Health care
Temp to PERM role
Key Skills
- Change Controls
- Design of Experiments (DOE)
- Pharma Quality by Design (QbD)
- Medical device Design control
- Risk management
Summary:
Develop, improve, and implement quality engineering program for facility, equipment (analytical and nonanalytical), product, process, computer systems, and methods development/improvement in the FDA regulated biologics, pharmaceutical and medical device industries.
Major Responsibilities
Qualifications
- Bachelor’s degree or equivalent in an Engineering or other technical discipline.
- 10+ years’ in Quality related role, with validation experience
- Experience from design conception through commercial implementation (e.g. URS, DQ, FAT, SAT, IQ, OQ, PQ) desired.
- Demonstrated ability to apply problem-solving methodology to identify the root cause and implement solutions.
- Experience in applied statistics – Design of Experiments (DOE), data analyses, sampling plans, process control.
- Experience data collection and statistical data analysis (e.g. capability analysis)
- Knowledge and experience with Change Controls, CAPAs, Quality Risk Management, FMEA.
- Applied Knowledge of Computerized System Validation (CSV) and Data Integrity Principles is desired (e.g. GAMP5 and 21 CFR Part 11).
- Experience in Facilities related validations is required (e.g. Cleanrooms)
- Fundamental knowledge of manufacturing processes. Ability to translate quality requirements into product specifications.
- Self-Starter with excellent technical understanding, writing and communication skills.
- Able to work with a diverse cross-functional team with minimal supervision.
- Ability to comprehensively document and communicate validation requirements and deviations encountered.
- Quality engineering concepts such as statistical analysis, quality testing, sampling and inspection, process control. Minitab and SAP knowledge a plus.
- Knowledge of ISO, ICH, GMPs, GLP, QSR, Biologics, 21CFR Part 211 and/or 820 regulations.
- Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated within the company in an efficient, timely, and accurate manner.