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Commissioning Engineer - API - Biopharmaceutical Company / England

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Location: , England
Salary:£50 - £60 per hour
Apjid3 View all jobs by this recruiter
My client is a Biopharmaceutical company based in the North West. Due to an expansion project they are looking for a Commissioning Engineer with API experiance 

Primary Function:
  • To provide Commissioning expertise to project teams on sites
  • To provide Commissioning expertise on our client sites when such requests arise (i.e. secondment type work)
Main Duties and Responsibilities:
  • Functional testing of equipment in an API manufacturing plant. Systems include dissolution, crystallization and solids isolation (pressure filtration), drying equipment, temperature-controlled units, nitrogen inertion and waste systems.
  • Preparation/review of commissioning documents, including water and solvent batch testing documents
  • Interfacing with representatives on project team, Construction, Engineering, package vendors, Automation, Quality and End Users.                                                               
Qualifications and Comments  
  • Educational Professional Qualifications Required                
  • Degree in Science or Engineering (or equivalent experience)
  • Relevant experience of Biopharma/pharma company in commissioning, engineering or operations
  • Hands- on experience of the start-up and on-going operation of pharma process and utility systems
  • Hands-on experience of process control system eg. DeltaV or equivalent
  • Proven hands-on experience of the operation of API process equipment ie dissolution, crystallization and solids isolation (pressure filtration) equipment, supporting utilities.
  • Knowledge of GMP regulatory requirements, equipment commissioning and qualification
Key Competencies: (Education, Training, Skills, Experience)
  • Commissioning Lead: A degree in chemical, mechanical, or electrical engineering or equivalent
  • Commissioning Lead: A degree in Chemistry, Microbiology, Physics, Biochemistry or equivalent.
  • A certificate/diploma in similar areas with appropriate industrial experience
  • Experience of Commissioning Qualification in the biopharmaceutical industry. (5-10 yrs)
Additional Competencies: (Education, Training, Skills, Experience)
In order of priority:
  • Experience of Commissioning in similar engineering company and project environment.
  • Experience of Commissioning in the general pharmaceutical industry. (3-5 yrs)
  • Experience with Regulatory and industry standards for GMP and GEP
  • Experience using the ISPE baseline guides
  • Self-starter
  • Good team player
  • Good oral and written communication skills

How to Apply

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