Overview
On Site
Full Time
Skills
IQ
OQ
PQ
Manufacturing
Collaboration
Storage
Project Documentation
Issue Resolution
Risk Assessment
Management
Computer Science
Life Sciences
Computerized System Validation
GMP
Pharmaceuticals
Biotechnology
Regulatory Compliance
Good Manufacturing Practice
Quality Management
Document Management
Communication
Documentation
Job Details
Responsibilities:
- Develop and execute CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment.
- Collaborate closely with automation and validation teams to ensure systems meet project and regulatory compliance standards.
- Manage the document lifecycle, including creation, revision, and storage, in compliance with project documentation systems.
- Participate in weekly project meetings to coordinate with system owners and management for alignment on project needs and issue resolution.
- Conduct risk assessments and generate compliance reports, managing deviations and ensuring all required documentation meets quality and regulatory standards.
- Oversee vendor interactions, including reviewing and tracking vendor deliverables and system qualifications.
- Bachelor's degree in a relevant field (e.g., Engineering, Computer Science, Life Sciences).
- Minimum of 5 years of experience in Computer System Validation in a GMP-regulated environment, ideally within pharmaceuticals or biotechnology.
- Strong knowledge of regulatory compliance requirements (e.g., FDA regulations, cGMP standards) and quality systems.
- Experience with DeltaV control systems and document management systems.
- Excellent organizational, communication, and documentation skills.
- bility to work effectively both independently and as part of an integrated project team.
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