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C&Q Lead - Syringe Filling - Pharmaceutical

  1. East
  1. Contract
Competitive
25530WP
  1. Commisions, Qualification and Validation
Date Posted25 Sep 2020

This vacancy has now expired

C&Q Lead - Filling line - Pharma - 11 months +

Experienced C&Q Lead required for a large scale expansion project.

We need an experienced C&Q Engineer with strong technical knowledge of sterile filling equipment to  oversee the commissioning & qualification  

Role &  responsibilities; 

  • Liaise with Suite Lead on all C&Q Activities
  • Lead the Suites C&Q activities, managing the Suite C&Q resources
  • Liaise with the various stakeholders on the Project C&Q team and the overall project
  • Participation in C&Q activities
  • Review and Input into technical requirement specifications and vendor turnover documentation.
  • Participate in C&Q deliverables (System Impact Assessment, Critical Component Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix)
  • Manage generation and execution of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
Skills & experience required:
  • Experience of leading C&Q activities on multiply equipment packages
  • Sterile Filling C&Q Equipment Experience
  • Knowledge of C&Q documentation required for cGMP process equipment.
  • Knowledge of regulations and standards affecting devices, biologics and pharma products.
  • Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM
  • Strong interpersonal and communication skills (verbal/written)
  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 5 years’ experience in commissioning and/or validation of USP/DSP/Facilities/Utilities systems within the Pharmaceutical industry.
  • Technical knowledge of Sterile Filling equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.

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