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Senior Validation Engineer

We are seeking CQV Engineers with 4-8 years' experience and we can assist with relocation costs.

Position Description: 

The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site. Other responsibilities include planning/coordinating work and directing small teams in document development and/or execution.

 

Requirements include: 

Position Requirements:

BS in a science or engineering field or equivalent years of experience

4-8 years' experience in commissioning and/or qualification activities in a regulated industry

Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues

High attention to detail

Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines

Ability to work independently, while quickly building and nurturing a project team

Expertise in Microsoft Word and Excel

Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus

Experience in planning / directing C&Q activities a plus

Must have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes


Other Requirements:

Excellent oral and written communication skills in English/Fluent in English

Able to travel domestically and internationally as required 

Able to work (paid) overtime 

Able to work in the US without sponsorship now or any time in the future. 


About CAI

CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 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.


Are You Ready?

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.


Benefits

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.

#LI-MV1


$87,152 - $94,600 a year
Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.

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). 

Average salary estimate

$90876 / YEARLY (est.)
min
max
$87152K
$94600K

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What You Should Know About Senior Validation Engineer, CAI

We're excited to announce that CAI is looking for a Senior Validation Engineer to join our dynamic team! If you have 4-8 years of experience in commissioning, qualification, and validation within regulated industries, we'd love for you to consider this opportunity. As a Senior Validation Engineer, you'll be instrumental in developing essential documentation that supports all aspects of Commissioning, Qualifications, and Validation processes. You'll be tasked with writing protocols, executing field verifications, and creating comprehensive summary reports right at the heart of client sites. A crucial part of your role will be planning and coordinating work while guiding small teams through the complexities of document development and execution. We value attention to detail and the ability to multi-task, so if you're someone who thrives on initiative and accuracy, you're already a great fit. Your expertise in technical problem-solving, along with a solid grasp of project technicalities, will elevate our team’s success. We take pride in our values at CAI, emphasizing teamwork, respect, and a commitment to excellence. With your skills in Microsoft Word and Excel, along with familiarity with ISPE Baseline Guide 5, you’ll contribute meaningfully to our mission. Plus, we’re thrilled to help with relocation costs if needed! Join us and become part of a 100% employee-owned company that values integrity, initiative, and a passion for service above all else!

Frequently Asked Questions (FAQs) for Senior Validation Engineer Role at CAI
What responsibilities do Senior Validation Engineers at CAI have?

At CAI, Senior Validation Engineers play a vital role in developing documentation essential for Commissioning, Qualifications, and Validation. They are responsible for writing protocols, executing field verifications, and compiling detailed summary reports directly at client sites, ensuring that all processes are thoroughly validated.

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What qualifications are required for the Senior Validation Engineer position at CAI?

To qualify for the Senior Validation Engineer position at CAI, candidates should possess a BS in a science or engineering field, or have equivalent experience. Additionally, 4-8 years of hands-on experience in commissioning and/or qualification activities in a regulated industry is required, coupled with strong technical problem-solving skills.

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What skills are essential for a Senior Validation Engineer at CAI?

Essential skills for a Senior Validation Engineer at CAI include excellent technical problem-solving and troubleshooting abilities. Candidates should also demonstrate high attention to detail, the capability to multi-task effectively, and possess strong oral and written communication skills in English.

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Does CAI offer relocation assistance for Senior Validation Engineers?

Yes, CAI is pleased to offer relocation assistance for Senior Validation Engineers, making it easier for qualified candidates to join our growing team regardless of their current location.

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What are the work culture and values at CAI for Senior Validation Engineers?

The work culture at CAI emphasizes integrity, teamwork, and commitment to exceptional service. Our employee-owned environment ensures that every team member's success contributes to collective achievements, highlighting respect for others and a strong can-do attitude in all our endeavors.

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Common Interview Questions for Senior Validation Engineer
Can you explain your experience with protocol writing as a Senior Validation Engineer?

In answering this question, highlight specific projects where you were responsible for protocol writing. Discuss the types of protocols you’ve developed, the stakeholders involved, and how you ensured compliance with industry standards, which is critical for roles like those at CAI.

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What steps do you take to execute field verifications?

Describe a systematic approach for field verifications, focusing on the planning phase, execution, data collection, and report generation. Emphasize your attention to detail and any tools you utilized to streamline the process, which aligns with CAI’s commitment to thoroughness.

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How do you handle technical challenges during commissioning or qualification activities?

Illustrate your problem-solving skills by mentioning specific challenges faced during past projects, your analytical approach to addressing those challenges, and the successful outcomes you achieved, which speaks to your fit for CAI's operational standards.

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Describe your experience with team leadership in document development.

Discuss instances where you directed small teams in the document development process, focusing on your leadership style, how you fostered collaboration, and how results were achieved. This reflects your ability to fit within CAI’s value of teamwork.

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What tools and software are vital for a Senior Validation Engineer, and how do you use them?

Mention familiarity with Microsoft Word and Excel specifically, and elaborate on how you've used these tools for documentation management and data analysis. Being specific about tools showcases your technical competency relevant to CAI's needs.

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How do you prioritize multiple tasks and meet deadlines?

Provide an example that illustrates your time management skills. Discuss prioritization techniques you use, and any tools or methods you've implemented to meet deadlines effectively, which is crucial for a fast-paced environment like CAI.

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Can you explain the significance of ISPE Baseline Guide 5 in your work?

Discuss your understanding of ISPE Baseline Guide 5 and its relevance to Commissioning and Qualification practices. Highlight any direct experience you've had applying its principles in projects, showcasing your knowledge and expertise relevant to CAI's focus.

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What does a successful commissioning project look like to you?

Paint a picture of success by detailing key performance indicators, quality benchmarks, and stakeholder satisfaction. This demonstrates your strategic thinking aligned with CAI’s philosophy of client-first service.

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Have you worked in a regulated industry, and how does that experience benefit you as a Senior Validation Engineer?

Share insights into your previous roles within regulated industries, discussing specific challenges and how you navigated compliance requirements. This aligns closely with CAI’s operational standards in FDA-regulated environments.

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How do you address communication barriers within your project teams?

Illustrate strategies you've implemented to overcome communication issues, such as regular updates, feedback loops, and technology utilization. Emphasizing your collaborative approach will resonate with CAI’s commitment to teamwork and respect.

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Full-time, on-site
DATE POSTED
January 5, 2025

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