Quality Engineer

Company: Aerotek
Location: White Plains
Posted on: January 11, 2021

Job Description:

Description:- Preparing and/or reviewing of validation protocols/reports (e.g. IQ, OQ, PQ), ensuring compliance and adherence to the design, customer and internal quality requirements, as applicable. - Responsible for leading and executing validation activities in a fast-paced cGMP manufacturing environment: review and approve executed qualification/validation documents, for facilities, processes, and equipment. - Conduct, and/or participate, in deviation investigations to identify root causes and define corrective/ preventative actions (CAPAs).- Organize engineering runs and validation activities with cross-functional teams to meet project objectives. Lead training of cross-functional teams involved in validation.- Support the review and evaluation of system design requirements (e.g. URS) and design phase implementation initiatives (e.g. FAT/SAT) - Represent Quality in cross-functional teams - Support process and product improvement initiatives and analyze product performance to identify trends as necessary.- Liaise with European design centers to ensure that design transfer and validation practices align with global requirements.- Drive technical quality activities to completion in accordance with project objectives/timelinesSkills:Validation, Quality engineering, Root cause analysis, continuous process improvement, Part 11, pharmaceutical, GAMP, investigation and analysis, medical deviceTop Skills Details:Quality EngineeringEquipment ValidationsProduct/Process InvestigationsAdditional Skills & Qualifications:- Bachelor's degree or equivalent in an Engineering or other technical discipline.- 5+ 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 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 desired (ex. cleanrooms)Experience Level:Intermediate Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, White Plains , Quality Engineer, Other , White Plains, New York