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Site Commissioning Engineer

Job Type:


Site Commissioning Engineer
Gartuna, Sweden

Main Duties and Responsibilities:
• Commissioning and Qualification of the following equipment:
• Docking Stations - component prep equipment that are steps before product is transferred to filling line
• Freeze Bag Thaw - component prep equipment
• Clean Utilities - Clean Compressed Air, Nitrogen, Pure Steam
• Vial Filling Line
• Syringe Filling Line
• GMP Parts Washer
• Sterility Isolators
• Interfacing with representatives on project team, Construction, Engineering, package vendors, Automation, Quality and End Users to obtain information and documentation as applicable, to allow completion of activities.

Qualifications & Experience:
• 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'S, 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 and Qualification in similar engineering company and project environment.
• Experience of Commissioning in the general pharmaceutical industry. (min 3-5 yrs.)
• Strong execution skills for IQ and OQ and report writing
• Experience with Regulatory and industry standards for GMP and GEP 
• Experience using the ISPE baseline guides
• Must have good GMP knowledge
• Must have Good GDP skills
• Raise deviation reports and closure
• Trouble shooter
• Team Player
• Self-motivated
• Good oral and written communication skills

At First Recruitment we understand just how important it is to secure the right people. That's why our consultants always take the time to understand requirements in detail and offer sound advice to both clients and candidates.

This is a superb opportunity for anyone looking to work for a reputable organisation.

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