Support the validation of software applications and computerised systems used in regulated pharmaceutical, biotechnology and medical device environments.
Responsibilities
Author, review and execute validation documentation and test protocols
Ensure software solutions meet defined requirements, regulatory expectations and quality standards
Collaborate with Software Development, Testing, Operations and Quality Assurance teams throughout the SDLC
Prepare, review and execute validation documentation including Validation Plans, IQ, OQ, AT protocols and Validation Summary Reports
Develop and maintain Requirements Traceability Matrices (RTMs)
Requirements
Degree in Computer Science, Engineering, Information Technology, Science or a related technical discipline
Nice to have: Validating software used in pharmaceutical manufacturing, automation or machine vision systems
Nice to have: Computer Software Assurance (CSA) principles
Nice to have: Agile software development environment
Drive validation of clinical data science processes, ensuring they are fit for intended use before they touch study data.
Locations (2)
Søborg, Capital Region, Denmark
Aalborg, North Denmark, Denmark
Compensation
For this role, the Annual Base Salary ranges from 742,600.00 DKK to 1,091,600.00 DKK, corresponding to the level of the position.
Responsibilities
Drive validation of clinical data science processes
Plan and coordinate validation for new or updated processes
Assess and document process risks
Prepare and maintain Process Validation Plans and Reports
Run risk-based walkthroughs and spot checks
Requirements
A degree in information technology, computer science, engineering, data science, life sciences or a related discipline, or equivalent relevant professional experience
Project Manager / Scrum Master (CSV & Compliance) to drive the end-to-end delivery of validated computerized system implementations, upgrades, and migrations, balancing traditional project management governance with Scrum Master facilitation under GxP regulations.
Responsibilities
Takes ownership of clearly defined, less complex tasks, smaller projects, or initiatives including validated system implementations, upgrades, and migrations.
Assists in outlining and documenting the scope for larger projects, pinpointing key components (validation scope and GxP impact).
Supports and contributes to the management of minor scope changes.
Maintains and refines the product backlog so that validation and compliance activities are planned alongside functional work.
Applies traditional project management governance including planning, milestone tracking, risk and issue management, and status reporting.
Lead digital solutions for clinical, regulatory, and enterprise systems to support RayzeBio’s radiopharmaceutical development and commercialization.
Locations (2)
Indianapolis, Indiana, United States
San Diego, California, United States
Compensation
Indianapolis - RayzeBio - IN: $166,139 - $201,322
San Diego - CA - US: $182,753 - $221,454
Responsibilities
Accountable for continuous operation and maintenance of digital solutions for Clinical Operations, Regulatory, Supply chain planning and related Enterprise Systems
Deliver on service level management scope and process with IT groups and/or vendor managed services
Ensure Digital Roadmap leveraged and aligned to business outcomes
Lead a group of indirect reports and service providers to deliver effective, innovative and stable solutions
The Automation CSV Engineer is responsible for supporting validation, compliance, testing, and technical documentation activities for GMP automation systems within a regulated manufacturing environment.
Compensation
The base pay range for this position at commencement of employment is expected to be $115,000 to $126,500; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Responsibilities
Develop and support lifecycle validation strategies for GMP automation systems
Define appropriate validation deliverables
Support new system implementations, expansions, upgrades, migrations, security updates, patches, and decommissioning activities
Evaluate automation changes for validation impact
Help ensure validated systems remain fit for intended use throughout their operational lifecycle
Requirements
Bachelor’s degree in Engineering, Computer Science, Information Systems, Biotechnology, Life Sciences, or a related technical discipline
comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability)
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