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MF01-080624 Project Manager

Puerto Rico

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Project Manager - Upgrade Change Management Program / Procedure
    • Define Change Management procedure aligned with corporate guidelines.
    • Develop Risk Assessment.
    • Develop and execute Implementation Plan.
    • Measure implementation success.

Qualifications:

  • Bachelor's Degree in Bachelor’s degree in science (Chemical, Engineering, Biology, Pharmacy or Microbiology).
  • Six (6) years of experience in project management, or relevant roles and responsibilities in a pharmaceutical industry
  • Experience in direct process / manufacturing areas.
  • Strong knowledge of relevant GMP, FDA, 21 CFR Part 11 and Data Integrity Regulations (Risk
    Assessment, Data Mapping etc), EU regulations and the ability to interpret and apply them for
    intended use.
  • Fully bilingual (Spanish/English) communication skills, both written and verbal.
  • Technical and scientific capability to make firm decisions and recommendations
  • Excellent interpersonal skills and the ability to interact with people at all levels
  • Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software
  • (database) and applications like Infinity and SAP
  • Available to work extended hours, possibility of weekends and holidays.

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