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Company

Original Job Post

Resilience · 2 days ago

Engineer IV, QC Systems

Ohio, United States

Full-time

Onsite

Senior Level

$80K/yr - $121K/yr

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BiopharmaBiotechnology

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Responsibilities

Participate as a key member of Digital QC system implementation projects, which may include requirements elicitation, technology evaluation, software configuration, customization, testing, validation, support, and end-user knowledge transfer.

Identify integration points with other systems (e.g., LIMS, LES, and Laboratory Equipment) and understand the technical architecture. Support data exchange activities with interfaced systems.

Define, implement, and promote mechanisms to ensure standardized implementation, operation, and maintenance of Digital QC Systems across all Resilience sites.

Participate in the development, implementation and maintenance of best practices, policies, standards, and procedures for Digital QC systems across the Resilience network.

Analyzing and designing new business processes along with identifying and defining detailed product requirements and use cases.

Document as-is and to-be states of QC processes; create and maintain detailed QC business maps, business requirements documents, and technical requirements documents.

Collaborate with Quality on initiatives and projects related to system implementation (e.g., integrations, data integrity and risk management).

Provides training and support to scientific staff in the use of automation systems.

Responsible for troubleshooting technical and validation issues that arise in the support of the support of Digital QC systems (EM/UM/Empower).

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

QC Computerized SystemsLaboratory Technology SystemsComputer Systems ValidationApplication DevelopmentSystems IntegrationIndustry StandardsGAMP5Technology AgnosticTechnical WritingFast-Paced Environment ManagementProblem-SolvingAdaptabilityCommunicationCollaborationProject PlanningDemand PlanningJiraConfluenceSmartsheetEnvironmental MonitoringUtilities MonitoringGxP ProcessesNovatekMODA

Required

Hands-on experience with the implementation of QC computerized systems (e.g., EM/UM/Empower) in the pharmaceutical or biotechnology industry is required.

Must possess strong knowledge of laboratory technology systems development life cycle, computer systems validation, application development or systems integration.

Knowledge of industry standards related to validated computerized systems and GAMP5.

Technology agnostic. Must possess the ability to adapt, learn and apply the correct technology at the right time.

Excellent oral and written communication skills with strong technical writing experience required.

Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders.

Preferred

Knowledge of project/demand planning tools (e.g., Jira, Confluence, Smartsheet, etc.)

Knowledge of Environmental Monitoring and Utilities monitoring processes.

Knowledge of GxP processes and systems.

Specific knowledge of Novatek and/or MODA.

Benefits

Equity

Annual cash bonus program

401(k) plan with a generous company match

Healthcare (including medical, dental, and vision)

Family building benefits

Life and disability insurance

Flexible time off

Paid holidays

Other paid leaves of absence

Tuition reimbursement

Support for caregiving needs

Company

Resilience

Resilience provides end-to-end biopharmaceutical manufacturing and development solutions.

Founded in 2020

La Jolla, California, USA

1,001-5,000 employees

https://resilience.com

H1B Sponsorship

Resilience has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (3)

2022 (6)