Computer System Validation (CSV) Engineer

A bit about us :

We are a fast-growing, Medical Device Manufacturer in Scottsdale, AZ, passionate about improving the lives of patients suffering from life-long pain.

We are hiring for a Computer System Validation (CSV) Engineer with strong knowledge in 21 CFR Part 11 and FDA and cGMP regulations and documentation practices.

Our ideal candidate will bring a minimum of 5 years relevant CSV experience, preferably in the life science, pharma, or medical device industry and be self-driven, able to "go" without a full plan in place and hold people accountable to quality standards.

Why join us?

Salary : $125-135k annually (Total comp $145k)

7% annual bonus

Relocation Assistance Offered for those not local to Scottsdale

Job Details

Job Details :

We are seeking a dynamic and experienced Permanent Computer System Validation (CSV) Engineer to join our fast-paced engineering industry team.

The successful candidate will play a pivotal role in ensuring the integrity of our computer systems and ensuring they are in compliance with internal and external regulations.

This position requires a high level of technical expertise, combined with excellent planning, coordination, and communication skills.

The CSV Engineer will be responsible for the validation of all computer systems, ensuring they meet the necessary requirements and industry standards.

This is an exciting opportunity for a professional looking to advance their career in a challenging and rewarding environment.

Responsibilities :

1. Execute and lead the validation of computer systems, ensuring compliance with 21 CFR Part 11, FDA regulations, and cGMP regulations.

2. Develop, review, and approve validation documents, including validation plans, test scripts, and final reports.

3. Coordinate and conduct validation activities in accordance with project timelines and business objectives.

4. Implement and manage document control processes and systems.

5. Evaluate and recommend improvements to existing systems and processes to enhance efficiency and compliance.

6. Provide technical support and training to other team members on computer system validation and related topics.

7. Participate in internal and external audits, ensuring all computer systems are compliant.

8. Oversee ERP implementation, ensuring seamless integration with existing systems.

9. Stay updated with the latest industry trends, regulations, and validation standards.

Qualifications :

1. Bachelor’s degree in Computer Science, Engineering, or a related field.

2. A minimum of 5 years of experience in Computer System Validation (CSV) in the engineering industry.

3. Proficient knowledge of Document Control, 21 CFR Part 11, FDA regulations, cGMP regulations, and CSV.

4. Proven experience in ERP implementation.

5. Strong understanding of computer systems, including hardware, software, networking, and security.

6. Excellent problem-solving skills and the ability to handle multiple projects simultaneously.

7. Strong written and verbal communication skills.

8. Ability to work in a team and independently as needed.

9. High attention to detail and accuracy.

10. Proactive, self-motivated, and able to work under minimal supervision.

11. Certification in Computer System Validation or a related field would be an added advantage.

This is a fantastic opportunity for a CSV Engineer to join a dynamic team and contribute to the success of our company. If you have the required skills and experience and are looking for a challenging and rewarding role, we would love to hear from you.