Position Overview: We are seeking a highly experienced and knowledgeable Lead CQV CIP Engineer to join our team in Holly Springs, NC. The ideal candidate will have extensive expertise in CIP systems within large-scale biopharmaceutical projects and will play a critical role in ensuring the successful design, commissioning, and qualification of these systems.
Main Responsibilities
Lead CQV Efforts for CIP Systems: Serve as the primary engineer for all CIP equipment in DSM buildings, overseeing the review of design deliverables including drawings, datasheets, specifications, and engineering lists.
Documentation Management: Lead the creation of all CQV CIP documentation such as FAT wraparounds, DQ, RTM, QRA, SAT/IOC, and IOQ, including final reports.
Vendor Coordination: Act as the point of contact for vendor reviews and ensure all CIP vendor packages meet project specifications.
Circuit Reviews: Lead reviews for all CIP routes and circuits, determining worst-case scenarios for testing and cleaning requirements.
Construction Liaison: Work closely with the construction manager to ensure construction readiness and manage the schedule for all CIP systems, including performing and leading field walkdowns.
Package Review: Oversee the review and approval of turnover packages, ensuring alignment with the Transition Group and covering both vendor and contractor packages.
Schedule Management: Collaborate with CQV PM and Lead Scheduler to create and manage schedules for CIP systems, ensuring proper sequencing and readiness for start-up and testing.
Commissioning Readiness: Ensure commissioning readiness of all CIP systems to support equipment start-up and IOQ testing.
Field Execution: Lead PSSR/STW field execution and guide the CQV team through the start-up exercise safely and efficiently.
Project Lifecycle Management: Liaise with all project groups to ensure comprehensive management of CIP systems throughout the project lifecycle.
CQV Documentation: Coordinate with the CQV Document Generation Lead for the generation and approval of key documents including DQ/Design Reviews, SLIA, Test Matrices, Risk Assessments, QA Vendor Assessments, FAT, SAT, CTP, and IOQ protocols.
Meeting Coordination: Run weekly CQV CIP meetings and provide updates to the broader CQV team.
Required Experience
Biopharmaceutical Equipment Expertise: Minimum of 10 years of experience with equipment on large-scale biopharmaceutical projects, including design and construction.
CIP Systems Specialization: At least 5 years as a subject matter expert (SME) on CIP systems.
CQV Team Experience: Minimum of 5 years on an equipment CQV team, handling complex projects in or around operating facilities.
Knowledge of Standards: Working knowledge of ASTM E2500 and leveraging verification processes.
Interdepartmental Liaison: Proven experience liaising with various departments and managing project managers and leads.
Education And Skills
Educational Background: Bachelor's degree in Engineering, Biotechnology, or a related field. Advanced degree preferred.
Technical Skills: Proficient in managing CIP systems, generating and reviewing CQV documentation, and understanding biopharmaceutical manufacturing processes.
Project Management: Strong project management skills with the ability to handle multiple tasks and lead complex projects.
Communication Skills: Excellent written and verbal communication skills, with the ability to effectively convey technical information and collaborate across teams.
Problem-Solving: Strong analytical and problem-solving skills, especially in identifying worst-case scenarios and ensuring system readiness.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering and Information Technology
Industries
Biotechnology Research
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