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