To acquire the advantage, Zolon PCS is seeking an Integration Engineer. This program will replace multiple decentralized and legacy quality management environments with a single, enterprise-wide platform that supports quality, compliance, training, audits, risk management, equipment management, supplier management, and corrective action processes across FDA Centers and Offices. The solution will support FDA organizations, including the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Human Food Program (HFP), Office of the Chief Scientist (OCS), Office of Inspections and Investigations (OII), and other FDA quality organizations.
Job Description:
Design, develop, configure, test, deploy, and maintain secure integrations between ComplianceQuest, Salesforce GovCloud, enterprise applications, cloud services, and external partner systems.
Implement and support REST, SOAP, batch, event-driven, and file-based integration solutions using approved middleware, API management, and integration technologies.
Develop and maintain API interfaces, data mappings, transformation logic, routing rules, orchestration workflows, and integration specifications.
Implement integration security controls, including authentication, authorization, certificate management, encryption, SSO, audit logging, and secure data transmission protocols.
Configure and maintain integration monitoring, alerting, logging, exception handling, reconciliation processes, and operational support procedures.
Support data migration, data synchronization, master data management, and system interoperability requirements across integrated platforms.
Perform integration testing, interface validation, defect remediation, performance tuning, and release readiness activities to ensure reliable and scalable operations.
Troubleshoot integration issues, perform root-cause analysis, and implement corrective actions to maintain system availability and operational performance.
Prepare and maintain interface control documents, technical specifications, configuration records, operational procedures, and compliance documentation.
Collaborate with architects, developers, cybersecurity personnel, business analysts, data migration teams, and customer stakeholders to ensure integration solutions meet business, technical, and regulatory requirements.
Ensure integrations comply with FDA regulations, GxP requirements, FedRAMP controls, Salesforce GovCloud standards, and organizational security policies.
Support operational sustainment, production support, continuous improvement initiatives, and enhancement activities throughout the system lifecycle.
Provide subject matter expertise for proposal development, technical solutioning, customer demonstrations, oral presentations, technical exchanges, and capability briefings.
Contribute lessons learned, best practices, reusable integration assets, and organizational knowledge artifacts to support business growth and continuous improvement initiatives.
Support development of innovative integration solutions based on experience gained through the FDA Cloud QMS Program and collaborate with corporate leadership to expand ComplianceQuest, Salesforce GovCloud, and Quality Management service offerings.
Requirements:
Minimum five (5) years of experience designing, developing, and supporting enterprise application integrations.
Experience implementing REST APIs, SOAP services, web services, and enterprise integration patterns.
Experience supporting Salesforce integrations, Salesforce GovCloud environments, or similar cloud-based enterprise platforms.
Experience with middleware and integration technologies such as MuleSoft, Boomi, Informatica, Dell Boomi, Azure Integration Services, or equivalent platforms.
Experience implementing SSO, OAuth, SAML, certificate-based authentication, encryption, and secure integration practices.
Experience developing data mappings, transformation rules, interface specifications, and integration documentation.
Experience in troubleshooting and supporting production integrations in complex enterprise environments.
Experience supporting integration testing, release management, and operational sustainment activities.
Experience working in FDA-regulated, Healthcare, Life Sciences, Federal Government, or other highly regulated environments preferred.
Knowledge of FedRAMP, cloud security, API security, and secure cloud architectures preferred.
Prior FDA experience is highly desirable.
Bachelor's degree desired.
Clearance: Ability to obtain Public Trust tier 2
Location: White Oak, Maryland (Hybrid)