Full-Time

Senior Validation Engineer

Updated on 4/30/2024

CAI

1,001-5,000 employees

Engineering and consulting for critical manufacturing facilities

Consulting

Senior, Expert

Indianapolis, IN, USA

Required Skills

Communications

Word/Pages/Docs

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
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
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

Responsibilities

Developing documentation to support Commissioning, Qualifications, and Validation
Protocol writing and execution, field verification, and development of summary reports at the client site
Planning/coordinating work and directing small teams in document development and/or execution

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.

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.

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

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).

CAI

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CAI offers a compelling work environment for professionals in engineering and consulting, particularly in the fields of pharmaceuticals, medical devices, and energy-efficient facilities. Their focus on enhancing operational readiness, managing risks, and improving productivity in quality-critical and mission-critical infrastructure ensures that employees are constantly engaged in meaningful and impactful work. This emphasis on critical industries also positions CAI as a leader in sectors that prioritize precision and innovation.

Company Stage

Pre-seed

Total Funding

$3.4M

Headquarters

Indianapolis, Indiana

Founded

1996

Growth & Insights

Headcount

6 month growth

↑ 1%

1 year growth

↑ 17%

2 year growth

↑ 15%

Benefits

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