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GMP Biotech Computer System Validation Specialist – Hybrid

  • Permanent
  • Anywhere

Website Pace Analytical Services, LLC

Pace Analytical Services, LLC

Company : Pace Analytical Services, LLC

Country: United States

Location : Frederick, Maryland

Post: Wed, 01 Feb 2023 20:52:56 GMT

Expires: Wed, 01 Mar 2023 23:59:59 GMT

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—————————— Job Description ——————————

OVERVIEW:

Make an impact. Build a career.

At Pace®, we’re committed to continuously moving science forward; to innovate and advance sustainable practices that improve the health and safety of our communities and lives. Ask any of us, and you’ll hear the same thing repeated again and again: we work here because what we do positively impacts the world.

If you’re curious, driven and inspired by the idea of doing important work with real-world impact, there’s no better place to build your career.

Find your place at Pace®

Join us as a Computer Systems Validation Specialist, where you’ll put your love of science to work in the Scientific Insourcing Services department. You’ll receive all the training you need to successfully take on your new role and grow an exciting laboratory sciences career at Pace®.

This individual will support computer system validation functions on client projects. Apply expertise cross functionally when required and demonstrates transferrable knowledge of computer system validation concepts.

Note: This is an evergreen posting for future positions within our team. If you would like to be considered during the next round of hirings and have the qualifications, please apply

RESPONSIBILITIES:
Experience related to pharmaceutical, biotech or device manufacturing facilities
Knowledge of GAMP 5 and 21 CFR Part 11
Competency with lifecycle approach to CSV
Familiarity with all aspects of CSV documentation, including risk assessments, design qualification, user and functional requirement specifications, IQ, OQ, PQ
Ability to author data integrity assessments and related protocols
Relies on extensive experience and judgment to plan and accomplish tasks and goals
Detail orientated with excellent written and oral communication skills
Ability to work independently to solve problems
Motivated, efficient, self-starter skilled in time management
QUALIFICATIONS:
Bachelor’s degree in Science, Engineering, or Computer systems, Preferred
5 or more years of industrial experience

IND2

About SPS at Pace Analytical: Like Pace®, our customers are continually innovating and looking for quality candidates to support their important work. As a member of the Pace® Scientific Insourcing Solutions team, you will have the opportunity to work directly with industry leaders who have scientific needs both inside and outside of the laboratory. OFCCP Statement: Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.

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