Job description

Senior CSV Quality Engineer

Medical Device

Start date: ASAP

$120,000 - $140,000

Remote

I’m working with a high-profile Medical device company. As their company is expanding they are increasing their staff base and are currently hiring for a Senior CSV Quality Engineer. This is a full-time Remote position.

This position will be ensuring the quality and regulatory organisation of systems. In this role you will be responsible for quality engineering and compliance activities of non-productive software. This includes performing software validation activities, for example: planning, assessing, executing and reporting for related tasks. The right candidate will also be responsible for providing compliance and technical support to the business owners of the non-product software applications as needed.

Key responsibilities:

- Implement and maintain a validation program for computer systems and automated equipment per applicable regulatory guidelines.

- Perform computer software Validation/Qualification activities.

- Work with business owners and 3rd party software venders to grasp an understanding of the workflow and functionality of non-product software.

- Manage and execute own CSV projects and manage project schedule.

- Manage CSV validation documentation.

- Write up and review validation deliverables including functionality requirements, validation plans and validation reports.

Requirements and expectations:

- BS or MS degree in information technology or related field.

- High skilled level of knowledge on all parts of the validation process.

- Hands on software validation experience in the biotechnology or pharmaceutical field.

- Broad and in-depth knowledge of computerised systems and regulatory requirements and current validation approaches to evaluate computerised systems.

- Strong knowledge of global regulatory requirements for validation, including current GAMP, ICH, USP, 21CFR11, 21CFR58, 21CFR210, 21CFR211.

- Strong written, verbal and communication skills.

Job Type: Full-time

Salary: $120,000.00 - $140,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Signing bonus

Education:

• Bachelor's (Preferred)

Experience:

• Computer System validation: 5 years (Required)
• Medical Device: 5 years (Required)
• Global regulatory requirements: 4 years (Preferred)
• Quality systems: 4 years (Preferred)

Work Location: One location

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