The Patient Safety Systems Principal Analyst serves as the business administrator for the GPS systems including the Global Safety Database (Oracle Argus). This position is responsible for providing oversight and management of the administration, maintenance and business function operational support of databases, with responsibility for more complex assignments.
KEY RESPONSIBILITIES:
· Design, configuration and implementation of advanced/complex system upgrades
· Create complex custom and ad hoc reports to meet growing business needs.
· Work closely with GPS management and business users to understand requirements and recommend solutions.
· Daily troubleshooting and problem resolution for end users
· Lead ongoing application administration tasks, coordination of the change control process to ensure timely development, testing and release of updates
· Project Management responsibility for GPS projects as assigned
· Work/Collaborate with Data, Technology and Engineering (DTE) teams
· May supervise other GPS Safety Systems staff
· Other projects and activities requested of department management.
*EDUCATION AND EXPERIENCE*
· Bachelor’s degree in computer sciences or related scientific engineering fields
· Minimum 5 years safety systems experience is required or the combination of education and experience
· Proficiency in MS Word, Excel and PowerPoint.
· Advanced Oracle Argus Safety systems experience (configuration and operational support) is required
· Advanced knowledge of Reporting Tools (RxLogix PV Reports, Toad/Toad Data Point, OBIEE or Power BI)
· Create complex custom/aggregate and ad-hoc reports to meet growing business needs.
· Strong presentation, communication (verbal and written) and interpersonal skills
· High proficiency in Oracle SQL
· Substantial experience in hands-on analysis and application support in a Windows O/S application environment supporting multi-tiered application architecture to include web based application clients
· Strong knowledge of GCP, FDA, EMA regulatory requirements as they apply to pharmacovigilance and working knowledge of safety database, and system life-cycle concepts
· Experience in the pharmaceutical or biotechnology industry
Company DescriptionFusion was founded to set a new standard in Health care consulting and staffing Industry. Our company is made up of Technical experts, dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. We offer Engineering and FDA remediation services for the Pharmaceutical, Bulk Drug Manufacturing, Biotechnology, Medical Device and Heath Diagnostic industries. Fusion was founded on the promise that we would provide a superior staffing experience for our clients by delivering the highest trained individuals.Now Hiring: Electrical Engineer 4
Location: Griffin, GA
Duration: 12-Month Contract
Shift: Day Shift
We are looking for an experiencedElectrical Engineer 4 to join an innovative engineering team supporting the design and development of advanced standby power solutions. If you have a strong background in electrical design, Creo, and power distribution systems, this is an excellent opportunity to work on challenging projects with a global industry leader.
Key Responsibilities:
Support engineering project leads and electrical team leads in developing subsystem and component designs
Design, detail, and release complete standby power solutions usingCreo
Provide purchasing, build, and commissioning support throughout the project lifecycle
Collaborate with local and international engineering teams
Investigate and support shop floor activities as needed
Required Qualifications:
Bachelor's Degree in Electrical Engineering (BSEE/BSEET) with8+ years of relevant experience
Associate's Degree with12+ years of highly relevant experience will also be considered
Master's Degree with6+ years of relevant experience will also be considered
Required Technical Skills:
• Creo Modeling
• Teamcenter
• AutoCAD (Basic)
• 480V & 208/120V AC Power System Design
• Power Distribution
• DC System Design
Preferred Skills:
• Creo Cabling
• Creo RSD
• TCP/IP
• J1939 & RS-485 Network Knowledge
Soft Skills:
• Excellent communication skills
• Strong organizational abilities
• Ability to thrive in a fast-paced, collaborative environment
Why Join?
• Work on cutting-edge engineering projects
• Collaborate with talented local and global teams
• Gain exposure to senior engineering leadership
• Contribute to innovative products used worldwide
Job Description:
Title: Biologics Instruments Qualification & Validation Lead
Location: Foster City, CA (Onsite)
Duration: Long Term Rolling Contract
Job Description:
Position Summary:
The Biologics Instruments Qualification & Validation Lead is responsible for ensuring that all analytical, bioanalytical, and process‐support instruments used in biologics development and QC/QA laboratories operate in a validated, compliant, and audit‐ready state. This role oversees the full lifecycle of equipment qualification (URS → DQ → IQ/OQ/PQ), manages risk‐based validation strategies, ensures data integrity (ALCOA+), and leads cross‐functional teams through regulatory‐aligned validation activities.
Key Responsibilities:
1. Equipment Qualification & Validation Leadership
2. Validation Documentation & Compliance
Author, review, and approve URS, DQ, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.Ensure documentation is audit‐ready, traceable, and compliant with Part 11, Annex 11, and ALCOA+.Maintain equipment lifecycle documentation including periodic reviews, requalification, and retirement.3. Data Integrity & Technical Controls
Implement and validate audit trails, access controls, electronic signatures, and backup/restore capabilities.Ensure validated state of instrument software, firmware, and connected systems.Partner with IT/Automation to validate networked instruments, integrations, and secure data flows.4. Cross‐Functional Collaboration
Work closely with QC, QA, Manufacturing, MS&T, R&D, IT, Facilities, and Vendors.Lead technical discussions with vendors to ensure qualification packages meet regulatory expectations.Provide SME guidance during change control, deviations, and CAPA investigations.5. Inspection Readiness & Regulatory Support
Prepare and support regulatory inspections (FDA, EMA, MHRA, PMDA).Lead mock audits and ensure validation packages withstand regulatory scrutiny.Respond to auditor questions with clear, defensible, science‐ and risk‐based rationale.6. Continuous Improvement
Drive improvements in validation processes using CSA principles, automation, and standardized templates.Implement best practices for instrument lifecycle management and data governance.Mentor junior validation engineers and elevate documentation quality across teams.Required Qualifications
Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or related field.7–12+ years of experience in equipment qualification, validation, or instrumentation engineering in a GxP biologics environment.Deep knowledge of GAMP 5, ICH Q7/Q9/Q10, 21 CFR Part 11, EU Annex 11, and global regulatory expectations.Hands‐on experience qualifying biologics‐specific instruments (HPLC, CE-SDS, flow cytometry, qPCR, bioreactors).Strong understanding of data integrity, computerized system validation, and laboratory workflows.Proven ability to lead cross‐functional teams and manage multiple validation projects.Preferred Qualifications
Experience with biologics QC release testing, potency assays, or analytical method validation.Experience validating cloud‐based or networked instrument software.Familiarity with LIMS, CDS, ELN, and MES integrations.Prior experience supporting regulatory inspections.Strong technical writing skills and ability to produce executive‐ and audit‐ready documentation.Core Competencies
Technical mastery of biologics instrumentationRisk‐based decision‐makingRegulatory interpretation and compliance mindsetCross‐functional leadershipStrong communication and documentation skillsProblem‐solving and deviation managementAbility to influence QA and stakeholders with data‐driven rationaleCompany DescriptionFusion was founded to set a new standard in Health care consulting and staffing Industry. Our company is made up of Technical experts, dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. We offer Engineering and FDA remediation services for the Pharmaceutical, Bulk Drug Manufacturing, Biotechnology, Medical Device and Heath Diagnostic industries. Fusion was founded on the promise that we would provide a superior staffing experience for our clients by delivering the highest trained individuals.
