Validation Engineer


AP Professionals
Published
March 30, 2021
Location
Rochester, New York
Job Type
Street Address
500 Linden Oaks

Description

AP Professionals has partnered with a medical company that is looking to add a Validation Engineer to their growing team.  The Validation Engineer will ensure regulatory compliance through developing and executing validations. Produce validation reports and develop and update procedures, work instructions, and forms.  Knowledge and experience in IQ/OQ/PQ required.

This is a full-time, direct hire role that offers room for growth!

Responsibilities

  • Develop and maintain the Master Validation Plan.
  • Develop and execute protocols supporting the Facility, Utility, and Cleanroom Qualification, Equipment Qualification, Process Validation, Cleaning Validation, and Test Validation.
  • Collaborate with other departments in order to develop strategies to test and validate the performance and reliability of equipment and processes.
  • Perform qualification testing in accordance with internal protocols/procedures or external standards and regulatory requirements.
  • Analyze validation test data to determine whether systems or processes have met validation criteria and support investigation into root cause of problems.
  • Produce validation reports such as statistical analysis, results analysis, observations, and conclusions.
  • Oversee technicians performing validations and mentor/train less experienced personnel on validation methodology.
  • Understand, communicate, and follow current Good Manufacturing Practices (cGMP’s).
  • Work with cross functional teams on projects relating to various validation topics and maintain an open and cooperative relationship in order to stay involved and promote teamwork.
  • Develop and update procedures, work instructions, and forms.
  • Assist with internal/external Quality System Audits.
  • Identify and implement improvements for existing processes (Corrective and Preventative Actions-CAPA).
  • Support facility, utility and operations related non-conformance reports (NCRs); root cause and corrective actions with a goal towards reduction and prevention.
  • Maintain accurate and compliant documentation to meet company, and regulatory expectations.
  • Support and adhere to the Quality Policy and Quality System procedures.

Education

  • Associates or Bachelor’s Degree in an engineering, technical or manufacturing discipline.
  • Certification in Project Management, Auditing or other validation related certification a plus.

Experience

  • A minimum of 2 – 10+ years' validation experience is required depending on level.
  • Detailed knowledge of IQ,OQ, PQ and ISO 13485 required.
  • Knowledge in validation and statistical tools such as Sampling Plans, Experimental Design and Optimization is desired.
  • Knowledge of current and applicable GMP regulations is required. Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations is required.
  • Knowledge or experience with quality audits preferred.

Knowledge, Skills, Abilities, and Other Characteristics

  • Ability to manage multiple projects simultaneously.
  • Excellent Communication skills, both oral and written.
  • Proficient in MS Office, MS Project, Minitab Statistical Software
  • Familiar with creating Project Plans and organizes resources to ensure project milestones are met within expectations of timeline, quality, and budget.
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