Senior Validation Engineer (Temp) de Belfast em Stryker Corporation

Data de Postagem: 8/6/2019

Resumo do Emprego

Descrição do Emprego

Senior Validation Engineer (Temp)

Oversight for the development and/or execution of plans, protocols, reporting, training/certification programs, and quality system documents associated with validation requirements for new or existing products and / or suppliers. May also include the development and execution of validation studies.

Your Key Responsibilities:

  • Build relationships to become a resource for process improvement, validation strategies, and technologies.
  • Develop, implement, or review process validation plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Develop or review of validation documents including user requirements, functional specifications, risk assessment, design description, and traceability matrices.
  • Coordinate with internal and external stakeholders to prepare validation designs and establish uniform specifications for processes and production equipment.
  • Assist in the evaluation of out-of-specification results and associated corrective actions.
  • Apply validation principles and requirements to process validation, equipment qualification, building, and facility qualification, test method validation, and/or cleaning validation systems.
  • Oversee validation activities of contractors and other employees.
  • Responsible for reviewing GMP documentation to support the validation effort including calibration, training, and preventive maintenance programs.
  • Supports programs that may affect the validated state which includes work instruction development, change control, and risk analysis.
  • Formulates and recommends validation guidelines, activities, and timelines in accordance with project objectives.
  • Delivers and presents technical and/or training presentations to management, employees, suppliers and contractors.
  • Actively pursues and enhances validation expertise.
  • Certification of those developing and executing validation activities.

What are we looking for?

  • Qualifications:

BS in mechanical or electrical engineering or degree associated with certain validations (i.e. chemistry, physics)

Certification/training through ASQ, AAMI, CfPIE, or equivalent.

  • Experience:

Minimum of 5 years’ experience in manufacturing environment or equivalent preferred.

  • System/Computer Requirements:

Basic Microsoft Office, MS Project, Adobe Acrobat

  • Key Competencies needed for this position
  • Able to generate and explain extremely detailed proposals, guidelines, and procedures.
  • Analyze and resolve complex process development issues of broad scope using independent judgment.
  • Observe and correct minute inconsistencies in the printed word, product appearance, etc.
  • Excellent analytical skills.
  • Excellent interpersonal communication and managerial skills.
  • Effective participant on multi-disciplinary teams.
  • Well-organized and detail-oriented.
  • Strong verbal and written communication skills.Excellent communication skills, both oral and written, required
  • Strong working knowledge with word processing and computer database programs including Microsoft Office Suite (Word, Excel, PowerPoint and Access)
  • Demonstrated ability to critically evaluate a process and determine the key components of that process as well as the issues that are constraining that process

Work From Home: Yes

Travel Percentage: Up to 25%

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