CQV Lead
- Denmark
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Our client, a global (bio)pharmaceutical manufacturing organisation, is recruiting for a CQV Lead to join them on their new expansion project. Based in a charming Nordic location, this is on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.
As CQV Lead, you will be responsible for the delivery of CQV activities on a complex drug manufacturing expansion project.
Responsibilities:
- CQV Lead Engineer for all Upstream & Downstream systems (Inoc, Media, Cell Culture, Harvest, UF-DF-Depth Filter-Viral Filter-Chromo-Purification-etc), initially responsible for timely review and approval of all CQV documentation, including but not limited to – EDR-DQ, SIA, FAT, RTM, QRA, RV, SAT, IOC, IOQ and Final Reports.
- Point CQV person for Vendor review for all Upstream/Downstream Vendor Packages.
- CQV SME for all Upstream/Downstream Systems.
- Liaise with EPCM in relation to construction readiness and a schedule for all Upstream/Downstream systems. Lead CQV effort for schedule review and readiness. Also perform and lead all field walk-downs for all Upstream/Downstream systems.
- Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for Upstream/Downstream Systems.
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Upstream/Downstream Systems, ensuring all correct predecessors and successors are in place.
- Ensure Commissioning readiness of all Upstream/Downstream Systems to support Equipment Start-up and IOC-IOQ Testing.
- Minimum of 10 - 15 years’ experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
- Experience with complex projects and within a CQV Lead capacity taking responsibility for a team of engineers.
- Experience within Drug Substance process areas such as Inoc, Media, Cell Culture, Harvest, UF-DF-Depth Filter-Viral Filter-Chromo-Purification etc.
- 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, local vendors, equipment suppliers and operations staff.
- Proven success working well in a team environment with flexibility to react to changing business needs.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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