Pace Analytical Services, LLC Looking for Automation and Computer System Validation (CSV) Specialist at Rockville, MD  Full Time

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 Automation and Computer System 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 provide hands on automation and computer system validation (CSV) specific to a data integrity and equipment remediation project at a biopharmaceutical company operating under cGMP. Full time support on location is preferred but hybrid scenarios may be possible.

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.

Perform data integrity gap assessments for individual pieces of cGMP equipment and/or equipment families
• Author and approve the QASR for each family and develop a comprehensive detailed remediation plan for each family of equipment. Equipment types include filter integrity testers, single use bioreactors, automated chromatography systems, etc.
• Implement each individual remediation plan and initiate change controls as required.
• Participate in the selection and procurement of software as specified in the plan for those equipment families which require new software; load software and assist Validation as needed in the development/execution of protocols.
• Implement configuration changes as specified for existing equipment software; assist in validation as above.
• Lead and/or contribute to the development of SOPs for access and administration of computerized systems specific to each equipment family
• Initiate/update Risk Assessments (RA) on system.
• Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements

• Bachelor’s Degree in Computer Science or IT/IS from a 4-year University; and/or Relevant experience in the CSV field
• Must have strong written and verbal communication skills
• Familiarity with GAMP5
• Must have a ‘hands on’ understanding of automation systems including DeltaV, OSI Pi Historian, Rockwell Allen-Bradley PLCs and plant network integration
• Prior experience working in GxP Industries with biopharmaceutical equipment is a plus.

IND2

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.

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.

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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