Engineer II Software Validation

Company: Strivector
Location: Immokalee
Posted on: June 21, 2022

Job Description:

BE THE CHOICE, NOT THE OPTION

Strivector specializes in catering to your specific desired company culture and purpose-filled job needs.

We help our clients meet their fast-growing business, new and existing positions with talented individuals like you.

Strivector works alongside Fortune 500, mid-sized and Start-ups for full-time and contract positions; on our list of companies, we have Bank of America, Fannie Mae, Philips, Smith & Nephew, Arthrex.

THE EMPLOYER

Take your career up a few notches with a global medical device company and a leader in new product development and medical education in orthopedics.

THE JOB

This is a Engineer II Software Validation position and requires someone who has Validation, 21 CFR Part 11 AND cGMP regulations, OR GxP computerized systems experience . As a Engineer II Software Validation your roles and responsibilities will include:

Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation.

Coordinate, assist and document validation activities; preparation/approval of protocols and reports.

Draft, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation. Examples include SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.

Perform revalidation and change control validation related activities.

Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.

Provide training to colleagues and contractors on our approach to systems implementation and validation SOP s.

Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering, business owners.

Develop and maintain Software Validation SOPs, forms, documentation and files.

Education and Experience:

Bachelor s degree in computer science, technology or related field required

3 years experience in the validation of computer systems, manufacturing, packaging, equipment and process, as well as utilities, and facilities qualification required.

Experience in thorough testing of applications, computerized systems, changes and implementations.

Knowledge and Skill Requirements/Specialized Courses and Training:

Ability to apply complex system validation principles to work assignments.

Must have thorough understanding of FDA regulations and computer validation guidance documents

Must be able to function independently, play a leadership role within a cross-functional team and address a variety of moderate to complex problems.

Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA.

Computer knowledge of 21 CFR Part 11, CFR 820

Excellent communication skills and customer service orientation

Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills: Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

We understand that even if you are a seasoned Engineer II Software Validation you may not have all the skills listed here. If you are a good at what you do and have a willingness to learn, lets talk.

ADDITIONAL INFORMATION

Compensation: Based on Experience. One of the best in the industry

Minimum Education: Bachelor s degree in computer science, technology or related field required

Minimum Experience: 3 years experience in the validation of computer systems, manufacturing, packaging, equipment and process, as well as utilities, and facilities qualification required.

Type of position: Full time Permanent Position with benefits

Telecommute: Yes

Location: Ave Maria, FL

Relocation accepted: Yes

Keywords: Strivector, Cape Coral , Engineer II Software Validation, IT / Software / Systems , Immokalee, Florida