Senior Validation Engineer

Cagents; Indianapolis (IN); On-site; USD 75,000 - 95,000; Full time

Job summary

Cagents is seeking a CQV Engineer to develop documentation and ensure successful commissioning and qualification within regulated industries. This role involves protocol writing, field verification, and directing teams, requiring a BS in a science or engineering field and several years of experience. A commitment to integrity and teamwork is essential in our employee-owned environment, which offers competitive benefits, including comprehensive health coverage and a substantial retirement contribution.

Benefits

15% Company Pension Contribution

24 days PTO and 5 sick days per year

Low-cost health insurance

Financial support for professional education

Company Paid Long-Term Disability

Qualifications

• 4-8 years' experience in commissioning and/or qualification activities.
• Experience in troubleshooting utilities and pharmaceutical manufacturing processes.
• Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus.

Responsibilities

• Develop documentation supporting commissioning, qualifications, and validation.
• Responsible for protocol writing and execution, and directing small teams.
• Plan and coordinate work effectively to meet deadlines.

Skills

Technical problem-solving

Troubleshooting

Attention to detail

Multi-tasking

Communication skills

Education

BS in a science or engineering field

Tools

Microsoft Word

Microsoft Excel

Job description

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.

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.

(Varies by Country, Below is a General Overview)

• Comprehensive Health Insurance coverage aligned with local region regulations
• Paid Time Off
• ESOP/401K – 15% Company Contribution (US Only)
• 15% Company Pension Contribution (Europe and APAC Regions)
• Company Paid Life Assurance
• Company Paid Income Protection/Long-Term Disability
• Career/Professional Development Opportunities
• Additional benefits/leave entitlements based on local regional requirements.