Commissioning, Qualification, & Validation Engineer

Company: (CAI) Commissioning Agents, Inc.
Location: Vancouver
Posted on: April 5, 2021

Job Description:

Commissioning, Qualification, & Validation Engineer Business Areas - Commissioning & Qualification / CAI is a 100% employee-owned company established in 1996 that has grown to nearly 600 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. Please check CAI out on Glassdoor to get a better perspective on our culture. We are extremely proud that our employee owners and others have given us so many 5-star ratings. 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 (our core values). That is how we have grown exponentially. Our full time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company. CAI CQV Engineers 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 patients. 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 employees benefit from our role as the leading commissioning / qualification firm in the world. Requirements include Position Description: The CQV Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Position Requirements: BS or MS in a relevant science or engineering field, or equivalent experience 2-15 years' experience performing commissioning and / or qualification activities in a regulated industry. Ability to generate commissioning and qualification protocols for multiple types of compounding equipment, integrated filling machines, closed stopper processing and clean utility equipment. Cycle Development for SIP and CIP Execution of IQ, OQ and PQ protocols Development of commissioning and qualification plans, risk assessments including SLIA and PFMEAs Familiar with FDA, EMEA and PICS regulatory requirements Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines. Ability to work independently, while supporting other team members. Excellent technical problem-solving and troubleshooting skills. High attention to detail. Expertise in Microsoft Word and Excel Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus Other Requirements: Excellent oral and written English is required Able to travel domestically and possibly internationally if required-- Able to work (paid) overtime-- Able to work in the US without sponsorship now or any time or in the future We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company.--We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).--

Keywords: (CAI) Commissioning Agents, Inc., Vancouver , Commissioning, Qualification, & Validation Engineer, Engineering , Vancouver, Washington