Full-Time

Staff Validation Engineer

Updated on 4/29/2024

CAI

1,001-5,000 employees

Engineering and consulting for critical manufacturing facilities

Consulting

Mid

Cambridge, MA, USA

Required Skills

Word/Pages/Docs

Requirements

BS in a science or engineering field or equivalent years of experience
2-4 years' experience in commissioning and qualification in a regulated industry
Experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation, or other pharmaceutical manufacturing processes
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 supporting other team members
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Excellent oral and written communication skills 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 for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment
Protocol writing and execution (field verification), and development of summary reports at client sites
Planning / coordinating work and directing small teams in document development and / or execution

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. 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

2-4 years’ experience in commissioning and qualification in a regulated industry

Ideally experienced 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 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 supporting other team members

Expertise in Microsoft Word and Excel

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

Other Requirements:

Excellent oral and written communication skills 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 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.

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.

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-MR1

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

View

Website

View Company Profile

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