Validation Engineer

CAI; Dallas (TX); On-site; USD 75,000 - 90,000; Full time

Job summary

An established industry player is seeking a Validation Process Engineer to join their dynamic team. This exciting role involves developing crucial documentation for the commissioning, qualification, and validation of pharmaceutical facilities and equipment. The ideal candidate will possess strong technical problem-solving skills and attention to detail, ensuring the execution of protocols and summary reports at client sites. With opportunities for professional growth and a supportive environment, this position is perfect for those looking to make a significant impact in a regulated industry. Join a company that values its employees and promotes diversity and inclusion in the workplace.

Benefits

Up to 15% retirement contribution

24 days PTO

5 sick days per year

Health insurance at low cost

Financial support for education

70% long-term disability paid

Qualifications

• BS in a relevant science or engineering field or equivalent hands-on experience.
• 2-4 years’ experience in commissioning or qualification activities.

Responsibilities

• Develop documentation for commissioning, qualification, and validation of facilities.
• Plan and coordinate work while directing small teams in document development.

Skills

Technical Problem-Solving

Troubleshooting Skills

Attention to Detail

Multi-tasking

Initiative

Communication Skills

Education

Bachelor's in Science or Engineering

Tools

Microsoft Word

Microsoft Excel

Job description

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

1. BS in a relevant science or engineering field, or equivalent years of hands on experience.
2. 2-4 years’ experience performing commissioning and / or qualification activities in a regulated industry.
3. Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
4. High attention to detail.
5. Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
6. Ability to work independently, while quickly building and nurturing a project team.
7. Expertise in Microsoft Word and Excel.
8. Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus.

Other Requirements

1. Excellent oral and written English is required.
2. Able to travel domestically and possibly internationally if required.
3. Able to work (paid) overtime.
4. 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.

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.

$75,000 - $90,000 a year. Average base salary range - not including benefits, and potential overtime and 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).

Seniority level

Entry level

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing