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Quality Engineer

Location : Valley Cottage NY US 10989
Job Type : Direct
Reference Code : 20642-MK1
Compensation : 70000.00 - 90000.00 USD/YEAR
Start Date : 07/20/2021
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Permanent position for a Quality Engineer responsible for leading and executing validation activities in a fast-paced cGMP manufacturing environment.

  • Review and approve executed qualification and validation documents for facilities, processes, and equipment.

  • Prepare and review validation protocols and reports (e.g. IQ, OQ, PQ), ensuring compliance and adherence to the design, customer and internal quality requirements.

  • Conduct and participate in deviation investigations to identify root causes and define corrective and 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.

  • Support the evaluation of existing system modifications to evaluate risk, and establish and implement a qualification strategy.

  • Interact 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 and timelines.

  • Support document creation or revisions as needed.

Required Qualifications :

  • BS Engineering

  • Minimum 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 (e.g. Cleanrooms).

  • Ability to comprehensively document and communicate validation requirements and deviations encountered.

  • Experience with quality engineering concepts such as statistical analysis, quality testing, sampling and inspection, process control. Minitab and SAP knowledge a plus.

  • Knowledge of ISO, GMPs, 21CFR Part 211 and/or 820 regulations.

Contact: Monique Kleiman

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