Project – Cqv
Engineer
Confirmed live in the last 24 hours
CAI

1,001-5,000 employees

Integrated services
Company Overview
CAI brings top-tier expertise to every stage of a project, from creating comprehensive, detailed project plans to achieving full-scale production operations, into rigorous asset management, reliability, and sustainability activities.
Consulting

Company Stage

Pre-seed

Total Funding

$3.4M

Founded

1996

Headquarters

Indianapolis, Indiana

Growth & Insights
Headcount

6 month growth

2%

1 year growth

16%

2 year growth

33%
Locations
London, UK
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Customer Service
CategoriesNew
IT & Security
Customer Success & Support
Requirements
  • Perform Commissioning, Qualification, Validation team activities with a direct regard for Safety
  • Generating C&Q Procedures for projects
  • CQV review/qualify equipment design - filling line (IMA / Optima)
  • Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans
  • Facilitate scoping / planning of commissioning spares and consumables
  • Deliver the C&Q activities as required to meet the schedule
  • Track progress of C&Q activities as required
  • Preparation of Qualification Summary Reports (QSR), and management of Requirement Traceability Matrix (RTM)
  • Execution of Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities
  • Coordinate with project contractors and equipment vendors to execute required tests
  • Allocate project resources for efficient execution of project deliverables
  • Coordinate support during C&Q execution
  • BS or MS in a relevant science or engineering field, or equivalent
  • 5+ years in CQV SME roles for life sciences - prior filling line (IMA / Optima) experience is desirable
  • Excellent oral and written communication skills
  • Excellent problem-solving skills
  • Customer-service focused
  • Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience
  • Able to travel domestically and internationally if required
Responsibilities
  • Our approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there
  • As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally: