Computer System Validation (CSV) Engineer
Location: Scottsdale
Posted on: June 23, 2025
|
|
|
Job Description:
Computer System Validation (CSV) Engineer with strong knowledge
of FDA and cGMP regulations and documentation practices and 21 CFR
Part 11. needed! (Full relocation provided) This Jobot Job is
hosted by: Ryan Sullivan Are you a fit? Easy Apply now by clicking
the "Apply Now" button and sending us your resume. Salary: $130,000
- $145,000 per year 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: $130-145k annually (Total comp
$155k with 7% bonus) 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. Interested in hearing more? Easy Apply now by
clicking the "Apply Now" button. Jobot is an Equal Opportunity
Employer. We provide an inclusive work environment that celebrates
diversity and all qualified candidates receive consideration for
employment without regard to race, color, religion, age, sex,
national origin, disability status, genetics, protected veteran
status, sexual orientation, gender identity or expression, or any
other characteristic protected by federal, state or local laws.
Sometimes Jobot is required to perform background checks with your
authorization. Jobot will consider qualified candidates with
criminal histories in a manner consistent with any applicable
federal, state, or local law regarding criminal backgrounds,
including but not limited to the Los Angeles Fair Chance Initiative
for Hiring and the San Francisco Fair Chance Ordinance.
Keywords: , Goodyear , Computer System Validation (CSV) Engineer, IT / Software / Systems , Scottsdale, Arizona
