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Senior CSV Quality Engineer

  • Permanent
  • Anywhere

Website ACE Partners

ACE Partners

Company : ACE Partners

Country: United States

Location : Long Beach, California

Post: Thu, 08 Sep 2022 20:24:06 GMT

Expires: Thu, 06 Oct 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— 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: $(phone number removed) – $(phone number removed) 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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