Overview
On Site
Full Time
Skills
GxP
Test Scripts
Software Development Methodology
Quality Management
Management
Risk Assessment
Collaboration
Agile
DevOps
Computerized System Validation
Life Sciences
Manufacturing
Risk Management
Corrective And Preventive Action
Test Management
Regulatory Compliance
Documentation
IQ
OQ
PQ
GAMP
Manufacturing Operations
Radio
Forms
MES
QMS
LIMS
Google Chrome
Business Analytics
Middleware
Testing
Application Lifecycle Management
ServiceNow
Job Details
Responsibilities:
- Provide application/system validation expertise for standalone, enterprise, and integrated systems in a regulated (GxP) environment.
- Lead OT system qualification and validation, including Client/DCS integrated with manufacturing equipment.
- Support qualification activities in Radio Ligand Therapy (RLT) or critical dosage forms (preferred).
- Author and review Validation Plans, Test Scripts/Protocols, and Validation Summary Reports.
- Ensure alignment with SDLC deliverables and IT Quality Management Systems (IT QMS).
- Conduct and manage risk assessments, deviations, investigations, CAPA handling, test management, and compliance activities.
- Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP5 guidelines and other regulatory requirements.
- Validate Standalone Systems and support ISA95-based manufacturing integration.
- Collaborate with Manufacturing, Quality, and Engineering teams to ensure successful validation and compliance.
- Consider OT Security requirements during qualification and validation projects.
- Contribute to Agile/DevOps-based validation approaches.
- 8-9 years of relevant experience in CSV/IT Quality & Compliance within the Life Sciences industry.
- Expertise in OT system qualification/validation, especially:
- Client/DCS systems integrated with manufacturing equipment.
- Radio Ligand Therapy (RLT) or critical dosage forms (preferred).
- Strong knowledge of Manufacturing, Quality, and Engineering system validations.
- Experience with risk management, deviation/defect handling, investigations, CAPA handling, test management & compliance.
- Hands-on experience authoring validation documentation (VP, IQ, OQ, PQ, VSR).
- Deep understanding of 21 CFR Part 11, EU Annex 11, GAMP5 guidelines.
- Familiarity with Standalone and Enterprise system qualifications.
- Knowledge of ISA95 architecture for manufacturing operations.
- OT system qualification in Radio Ligand Therapy or critical dosage forms.
- Client/DCS qualification with integration experience.
- Knowledge of MES, QMS (Track Wise), LIMS, Empower CDS, Chrome Leon, Business Analytics, Middleware systems.
- Experience with OT Security requirements in regulated environments.
- Hands-on experience with testing/validation tools such as:
- Client ALM.
- Kneat.
- ServiceNow (SNOW).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.