Computer System Validation Engineer, Quality

Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.
IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Genomic Medicines Quality Assurance Department located in Coralville, IA and will be hybrid on-site 3 days a week. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things.
In this role, you will have the opportunity to:

• Project management, including timeline and resources, coordination with QA management regarding priorities and organization of departmental resources to support CSV activities (i.e., validation resources, as well as IT and business process owners). Work with Manufacturing (MFG), Facilities (FAC), Quality Control (QC), Quality Assurance (QA) and Information Technology (IT) to schedule CSV activities.
• Generate, revise, and execute CSV documentation for analytical instruments, process equipment, and facility Computer Systems and software ensuring compliance with 21 CFR Part 11, ICH Q7 Sections 12 and 13, GAMP and other regulatory and industry standard requirements as deemed necessary. Partner with Quality Systems and IT to ensure policies and procedures reflect up-todate regulatory expectations for CSV.
• Generate, revise and/or review plans, policies, procedures, reports, specification documentation and vendor qualification documents related to CSV; including but not limited to; protocols (IQ/OQ/PQ), URS's, FRS's, test plans, trace matrices, technical reports, and CSV summary reports using Good Documentation Practices (GDPs). Investigate and resolve exceptions, nonconformances, deviations and resolutions, CAPA's, and change controls related to CSV protocols.
• Demonstrates behavior consistent with the Integrated DNA Technologies Core Values.
• Performs other duties as assigned.

The essential requirements of the job include:

• B.S. degree in engineering, biology, chemistry, computer science, mathematics, or similar discipline
• 2-4 years of experience in Validation or Quality Departments
• Knowledge of the regulatory and cGMP regulations for pharmaceutical manufacturing operations, and validation procedures and practices, including 21 CFR Part 11, Annes 11, industry guidance, such as GAMP 5, experience with a variety of software applications and operating systems.
• Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management. Ability to work well with diverse, multi-disciplined groups and effectively communicate with management and fellow project team members.
• Attention to detail - it is vital that Validation Engineers follow validation protocols precisely to ensure that the results are reliable, demonstrated understanding of cGMPs, ability to apply cGMPs and recognize variances from cGMPs.

It would be a plus if you also possess previous experience in:

• Suitable experience and knowledge in the area of Computer System Validation (CSV), remediation and implementation, in lieu of degree, will be considered.
• Experience with qualifying systems such as LIMS, ERP, CMMS, BMS, analytical systems, and processes, and experience drafting Validation Master Plans and Validation Project Plans.
• Ability to work independently with initiative, good planning and organizational skills, flexibility for changes in work priorities and amount of activities.

When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
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