Validation Engineer

Mayaguez  /  Puerto Rico  /  Contract


About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to over 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to 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.
As owners of 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
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine 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.
 
Requirements include:
Position Description: 
The Validation Engineer (CQV & CSV) will manage and/or apply extensive technical validation engineering expertise in the coordination of multiple, complex, routine and/or non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems/equipment, manufacturing processes or facilities. Will apply industry wide technical validation knowledge in development of novel approaches to routine and/or non-routine projects.
 
Also, will 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 summary reports and/or presentations to communicate project status, issues, and timing to CAI clients.
 
Position Requirements: 
BS or higher (MS) in Science (Chemical, Biology or Microbiology) or Engineering (preferably Electrical, Mechanical, Chemical or Computer) or any related discipline.
At least five (5) years of experience validating/qualifying computerized systems and mechanical equipment in the manufacturing and packaging, utilities, and laboratory environment.
Formal training in validation methodologies, technologies, and process control computer systems.
Knowledge on computerized system with data collection software (database).
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.
At least three (3) years of experience working with PLC’s, Industrial Computers, or laboratory instrumentation systems.
Background in pharmaceutical, biotechnology and medical device products manufacturing environment.
Good skills writing validation/commissioning, and technical documentation in English and using MS Office applications.
Excellent skill in leading teams to perform complex tasks under pressure.
Customer-service focused.
Excellent problem-solving skills
Bilingual (both English/Spanish) 
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CAI BENEFITS

(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • Other Benefits Depending on Country