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CQV Upstream Engineer

  1. Denmark
  1. Contract
Competitive
  1. CAPEX Projects
06-12-2023
31401
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CQV Upstream Engineer- Life Science- Contract- Denmark

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV Upstream Engineer to join them on their new expansion project. Based in a charming Nordic location, this on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.

As CQV Upstream Engineer, you will be responsible for the delivery of CQV Upstream Engineer activities on a complex drug manufacturing extension project.

CQV Upstream Engineer Responsibilities:
  • CQV Engineer for Equipment in the Upstream Area for the Drug Substance Manufacturing Facilities, initially responsible for review of all Design deliverables from EPCM and Vendors including Drawings, Datasheets, specifications, and Engineering Lists.
  • Experienced in Inoculation, Media, Cell Culture, Harvest ect.
  • Support generation of all CQV Upstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
  • Generate Upstream Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
  • Point CQV person for Vendor review for all Upstream Vendor Packages.
  • Liaise with EPCM in relation to construction readiness and a schedule for all Upstream systems, perform and lead all field walkdowns for all systems.
  • Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for all Process Equipment Support systems. 
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Upstream Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Upstream Systems to support Equipment Start-up and IOQ Testing.
  • Support execution of all Upstream systems and CQV deliverables; FAT/SAT/IOQ
  • Run Present at CQV Upstream Meeting and ensure updates are provided to Weekly CQV Meeting.
  • Generate and ensure timely approval of all SAT and IOQ Final Reports.
About you:
  • Minimum of 3 years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities. 
  • Ability to keep work pace and meet deadlines. Good organising and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
Are you a good fit for a CQV Upstream Engineer? Get in touch with us today.

The candidate must have the rights to work in the location stated in the job advert.

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