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
Click
here to apply!
|