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GMP Biotech Computer System Validation Specialist - Hybrid

PACE

Frederick, MD | Full Time

$79k-94k (estimate)

3 Weeks Ago

GMP Biotech Validation Specialist - Hybrid

PACE

Frederick, MD | Full Time

$55k-69k (estimate)

3 Weeks Ago

GMP Biotech Computer System Validation Specialist - Hybrid

PACE Frederick, MD

$79k-94k (estimate)

Full Time | Wholesale 3 Weeks Ago

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PACE is Hiring a GMP Biotech Computer System Validation Specialist - Hybrid Near Frederick, MD

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

What you'll do

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

What you'll bring

Bachelor's degree in Science, Engineering, or Computer systems, Preferred
5 or more years of industrial experience

What we promise

Comprehensive benefit program, including medical, vision and dental insurance, 401(k) matching and a tuition reimbursement program
Opportunities to build a rewarding career
An inclusive culture that stands for integrity, innovation and growth

About Pace®

PaceⓇ Science and Technology company makes the world a safer, healthier place. We partner with clients to provide the service, science, and laboratory data needed to make critical decisions that benefit us all. Through a nationwide laboratory network, PaceⓇ advances the science of businesses, industries, consulting firms, government agencies, and others. More at PACELABS.com.

PaceⓇ Analytical Services is a division of PaceⓇ Science and Technology, providing local testing and analytical services backed by a large, national laboratory network.

PaceⓇ Life Sciences is a division of PaceⓇ Science and Technology, providing full-service CDMO/CRO capabilities and professional services for in-house labs through a nationwide network of service centers, manufacturing sites and FDA-registered laboratories.

Requirements:

Pace® Life Sciences

Pace® makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace® provides professional services to support their operations.

Req Benefits:

Benefits

80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.

Equal Opportunity Employer

Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.