Full-Time

Validation Engineer Senior 2

CAI

1,001-5,000 employees

Integrated services

Consulting

Senior, Expert

San Francisco, CA, USA

Required Skills

Word/Pages/Docs

Requirements

BS in a relevant science or engineering field or equivalent years of hands-on experience
8-12 years' experience performing commissioning and/or qualification activities in a regulated industry
Excellent technical problem-solving and troubleshooting skills
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 and quickly build and nurture 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
Excellent oral and written English
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 in the future

Responsibilities

Developing documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment
Responsible for 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 Validation Process 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 relevant science or engineering field, or equivalent years of hands on experience

8-12 years’ experience performing 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

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

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-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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Website

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CAI brings top-tier expertise to every stage of a project, from creating comprehensive, detailed project plans to achieving full-scale production operations, into rigorous asset management, reliability, and sustainability activities.

Company Stage

Pre-seed

Total Funding

$3.4M

Headquarters

Indianapolis, Indiana

Founded

1996

Growth & Insights

Headcount

6 month growth

↑ 2%

1 year growth

↑ 19%

2 year growth

↑ 22%

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