Senior Validation Engineer

CAI; Lower Providence Township (PA); On-site; USD 102,000 - 112,000; Full time

Job summary

CAI is seeking a CQV Engineer to develop documentation for the commissioning, qualification, and validation of pharmaceutical facilities and equipment. With 4-12 years of experience in a regulated industry, the ideal candidate will demonstrate strong technical problem-solving skills and initiative, working autonomously while supporting team efforts. This position offers competitive compensation and a strong focus on client satisfaction.

Benefits

Up to 15% retirement contribution

24 days PTO and 5 sick days per year

Health insurance at low cost

Financial support for professional education

70% long-term disability paid by the company

Qualifications

• 4-12 years' experience in commissioning and qualification in a regulated industry.
• Familiarity with ISPE Baseline Guide 5 is a plus.
• Able to travel domestically and internationally.

Responsibilities

• Develop documentation for Commissioning, Qualification, and Validation of pharmaceutical facilities.
• Plan and coordinate work; direct small teams.

Skills

Technical problem-solving

Troubleshooting

Attention to detail

Multi-tasking

Initiative

Communication skills

Education

BS in a science or engineering field

Tools

Microsoft Word

Microsoft Excel

Job description

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

4-12 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.

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 (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

$102,100 - $111,700 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).