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Validation Engineer

Validation Engineer

PharmEng Technology Americas00968, PR, US
Hace más de 30 días
Descripción del trabajo

Job Description

Job Description

As a global organization, PharmEng Technology has been providing quality services to leading manufacturers of the Pharmaceutical and Biotech industries since 1997. Our employees come from diverse backgrounds where we value unique talents and work together to support our clients. In addition, our consultants have extensive experience obtained from world-class organizations across the globe, and the development of our staff continues to grow PharmEng Technology.

We are seeking an experienced Validation Engineer in Dorado, Puerto Rico.

Objectives of this Role :

  • Write and execute, Installation Qualification (IQ), and Operational Qualification (OQ) protocols and Summary Reports including thorough resolution of protocol discrepancies.
  • Assess potential sources of variation in materials, processes, facilities, equipment, products, and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources.
  • Maintain an up-to-date knowledge of validation requirements, practices, and procedures.
  • Interpret existing Validation Plans and Project Plans and apply concepts to the task at hand.
  • Working with a team to ensure all aspects of activity within the Process Development and Validation group adhere to required policies and procedures, including safety and training.
  • Investigate / troubleshoot validation problems, as well as, conduct some statistical analysis of testing results.

Skills and Qualifications :

  • More than 5 years of experience in the industry (preferably with experience in medical devices).
  • Experience executing semi-automatic equipment validations (Debug, IQ / SQ, Process Characterization, OQ / PQ, etc.).
  • Technical knowledge.
  • Knowledge of software and / or PLC is an advantage.
  • The candidate must be committed to the project and work in person daily. Distance should not represent a risk of abandoning the project early.
  • Willing to work overtime or weekends if necessary.

    • Our Benefits :

  • Health, Dental, and Vision Insurance Benefits
  • Training Opportunities and Career Development
  • 401k plan with Employer Contributions

    • PharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. PharmEng offers continuous career growth, competitive wages, travel opportunities, a team mentality that sets us apart from our competitors, and more!