Pharmaceutical Plant Qualification Specialist

1 settimana fa


Latina, Lazio, Italia VTU A tempo pieno

Pharmaceutical Plant Qualification Specialist (m/f/d)

Possible Work Locations

Various locations

Employment Type

Full-time

As a seasoned Pharmaceutical Plant Qualification Specialist, you will oversee the commissioning and validation processes of pharmaceutical facilities, alongside their design aspects. Your role will involve the technical and organizational management of the entire project lifecycle.


Key Responsibilities

  • Managing and executing projects
  • Developing User Requirement Specifications (URS), System Life Cycle Impact Assessments (SLIA), and Computerized System Life Cycle Impact Assessments (CLIA)
  • Creating various qualification protocols (IQ/OQ/PQ)
  • Compiling validation summary reports
  • Establishing traceability matrices
  • Conducting risk assessments
  • Overseeing the commissioning of facilities
  • Performing qualification and validation tasks for essential equipment and clean utilities in compliance with GMP standards
  • Implementing process designs and calculations throughout different project phases
  • Preparing Process Flow Diagrams (PFDs) and Piping and Instrumentation Diagrams (P&IDs)
  • Addressing customer specifications
  • Drafting tender documentation and aligning with suppliers

Candidate Profile

You possess a Diploma or Master's degree in Process Engineering and have substantial experience in the Pharmaceutical Industry or within a process engineering firm, particularly in the pharmaceutical or biotech sectors. You are accustomed to working autonomously while being part of a professional team.

Our Offer

We provide a diverse range of challenging tasks within a committed team and an outstanding work environment. We encourage proactive engagement, offer flexible working hours, and support both internal and external training opportunities.

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