Crest Solutions have an opening for a Commissioning and Qualification engineer to join our team on a 12-month contract basis to support projects including New Process Introductions, Equipment Recap and new Processing Technology.
Responsibilities
- Lead C&Q asset delivery for assigned projects (planning, scheduling, execution and handover).
- Specific C&Q Activities:
- System User Requirements
- C&Q Risk Assessments
- C&Q document prep (C&Q Plans, Test Protocols and Reports)
- Vendor & Contractor coordination and supervision (offsite and onsite)
- Review and acceptance of contractor and vendor handover documentation
- Acceptance of systems at Mechanical Completion
- Safe energization and start-up of equipment and systems
- C&Q field execution (FAT, SAT, RV, IV, FT)
- Running recipes, sequences and functional testing via DCS
- Troubleshooting and resolving design, installation, and operational issues for systems under test
- Project Change Control and Discrepancy Management
- Handover of systems to User Team
- Commissioning and Qualification of Process Equipment, Utilities and Facilities
- Minimum of 10 years of experience in GMP pharmaceutical design / build / commission / start-up with direct responsibility for Engineering Documentation, Project Execution or Facility Design.
- Experience with design, construction or commissioning of a drug substance, drug product or finished product facility.
- Direct experience in a similar scale project
- Experience of Validation /Verification / CQV of GMP equipment or processes would be beneficial.
- Demonstrated ability to organize and lead a multifunctional team in support of defined objectives.
- Ability to constructively challenge, defend and present technical aspects of design and commissioning.
