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Upstream C&Q Engineer

  1. Eastern Europe
Zagreb-dio
  1. Contract
Competitive
  1. Compliance / Quality Assurance
01-05-2024
32451
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Upstream C&Q Engineer - Life Sciences - 12-Month Contract - Zagreb, Croatia 

Our client, One of the world’s largest pharmaceutical organisations is responsible for developing and manufacturing medicines and vaccines for a wide range of medical disciplines. They have been responsible for the development of many blockbuster drugs in both the USA and the EU and have a presence in the USA, EU and Asia-Pacific.

With continued organisational growth and a considerable amount of investment across the portfolio and capital programme they are seeking the expertise of an Upstream C&Q Engineer. 


Key Responsibilities:
  • Execute, Review and support vendor testing (e.g. SAT / CTP / VTP)
  • Execute Delta V testing in accordance with approved Automation design and record test discrepancies for further analysis in accordance with DS3 Engineering Change Controls procedures
  • Documentation of the test results in the relevant test/Commissioning/Verification documents according to GDP
  • Participate to the daily morning meetings
  • Participate on Walk Down/Safety Walk Down and be responsible of the execution of safety measures
  • Check the availability of the accurate work permits (if required)
  • Track issues and punch items
  • Initiate and support resolution of technical issues and escalate in case no solution is found
  • Assess if commissioning/verification actions affect other discipline and escalate to the lead
  • Coordinate field activities of vendors and contractors
  • Attend daily Whiteboard meetings to contribute to overall C&Q priority list

Requirements:
  • Bachelor of Science or similar qualification in Technical Field (engineering, life science, or equivalent) from accredited institution is advantageous.
  • Minimum 3 years technical experience - Strong Pharmaceutical Process knowledge is desirable
  • Experience in a pharmaceutical / FDA-regulated manufacturing environment.  A solid working knowledge of cGMP and facility/equipment qualification requirements.
  • Hands on experience working on a greenfield capital project
  • Experienced in commissioning protocol drafting
  • Upstream experience – Bioreactors, Harvest, Homogenization, Centrifuge, Media & Buffer Prep/Hold
  • Experience with testing of automated manufacturing equipment / systems (e.g., Delta V / PLC-controlled equipment) is desirable.
  • Ability to write clearly, concisely, and persuasively in a professional environment and follow GEP / GMPs

If this role is of interest to you, please apply now! 

 #LI-FB1
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