Validation Engineer (CQV/CSV)
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Meeting a Higher Standard.
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.
In CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
CAI agents will be exposed to cutting edge technologies in the advanced medicine/pharma space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
The Validation Engineer (CQV&CSV) should have minimum 6 to 8 years experience in validation activities for Design, Planning & Execution of Commissioning & Qualification of Bio Pharmaceutical facilities for Biotech, Fill Finish, Sterile, Oral Solid Dosage (OSD), medical devices for manufacturing Process systems/Clean Utilities, CSV Process Automation, Clean Room Facility Commissioning, Qualification Verification. Knowledge in required regulations, Industry standards is mandatory.
Also, would lead, manage, and coordinate multi-discipline site executions. Will be responsible of supporting clients CQV and CSV programs and its implementation within the projects. The Validation Engineer (CQV & CSV) must develop overall documentation and execution strategy, track progress against plans, prepare costing models, and could monitor actual project costs against project budget. The Validation Engineer (CQV & CSV) must also prepare URS, Risk Assessments, CQV Protocols, Design Review Reports, Summary reports, Operation SOPs and/or presentations to communicate project status, issues, and timing to CAI clients.
Candidates with strong CQV/CSV experience for Process equipment/Utility Systems/ Facility for Biotech/ Lifesciences/ Pharma consulting engineering industry will be given preference.
BE/B Tech or higher (MTech/MS) in Science (Chemical, Biotechnology, Pharmacy or Microbiology) or Engineering (preferably Mechanical, Chemical) or any related discipline.
At least 6-8 years of experience validating/qualifying manufacturing process equipment, auxiliary systems, Clean Utility & Black Utility systems, Facility, computerized systems and mechanical equipment in the manufacturing, packaging, Utility area, warehouse area, and laboratory environment.
Formal training in validation methodologies, technologies, and process control computer systems.
Knowledge on computerized system for Manufacturing Process systems, Utility and Facility Knowledge with network communications protocol (i.e., TCP/IP).
Strong knowledge of cGMP (Parts 210 & 211), 21 CFR Part 11 and Data Integrity Regulations.
Basic knowledge in Project Management concepts and methodology.
Basic knowledge in CQV & CSV concepts and methodology.
Acquainted with GAMP5 methodology for validations.
Background in pharmaceutical, biotechnology and medical device products manufacturing processes, systems & the Environment