Website ICONMA, LLC
ICONMA, LLC
Company : ICONMA, LLC
Our client, is a Biotech company, is looking for a Senior Computer System Validation Consultant (GxP) for their San Diego, CA location.
Responsibilities:
- Lead the enhancement and maintenance of the site's Computer System Validation (CSV) program, providing critical Quality Assurance oversight and technical validation expertise for all computerized systems.
- Reporting directly to the Site Quality Head, you will ensure that all IT and automated systems—ranging from laboratory and manufacturing to quality support—are implemented, validated, and maintained in full compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 standards.
- You will act as the Quality Lead for project teams, guiding validation activities throughout the system lifecycle and ensuring inspection readiness for all computerized systems.
Validation Lifecycle & Governance
- Deliverable Management: Author, review, and approve critical validation deliverables, including:
- Validation Plans, Risk Assessments, and User Requirements Specifications (URS)
- Configuration Specifications, Design Specifications, and Traceability Matrices
Test Scripts (IQ/OQ/PQ) and Validation Summary Reports
- Perform requalification of existing computer systems and support Periodic System Reviews to maintain a validated state.
- Oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release, update, or iteration.
- Define and oversee system development processes to ensure compliance is embedded at every stage of the lifecycle.
Project Leadership & Cross-Functional Collaboration
- Act as the Quality Lead for project teams, guiding the implementation of validation, security, and project management deliverables at appropriate stages of the system lifecycle.
- Collaborate closely with cross-functional GxP partners, including IT, Engineering, Manufacturing, Quality Control, and Validation teams.
- Provide expert guidance to project teams on compliance and security control requirements to ensure data integrity and system reliability are integrated by design.
Operational Compliance & Audit Readiness
- Review and approve system lifecycle documentation generated by project teams to ensure alignment with local SOPs and global regulatory expectations.
- Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA), and support the execution of corrective action plans.
- Apply thorough knowledge of risk management processes to identify, mitigate, and escalate critical compliance findings or security risks to appropriate leadership.
- Prepare management reports regarding compliance operations, project progress, and the overall validated state of site systems.
Legacy Systems & Technical Integration
- Support evaluation of existing legacy systems for technical integration and tool management.
- Perform gap assessments and risk assessments on legacy systems, identifying remediation needs and developing mitigation plans.
- Advise on the implementation of compliance and security controls for both new and existing systems.
Continuous Improvement & Culture
- Drive the enhancement of Quality Compliance operating procedures to bridge gaps between local practices and global quality expectations.
- Align daily actions with department goals and company culture, actively promoting teamwork across all functions with a patient-first mindset.
- Foster and embrace an environment of teamwork, accountability, and responsibility that supports the manufacture of a quality product.
Requirements:
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline (an equivalent combination of education and experience may be considered).
- Minimum of 8+ years of experience in the Life Sciences industry (Consulting or Industry) with a focus on Computer System Validation and Quality Compliance.
Expert understanding of:
- FDA 21 CFR Part 11, 210/211, and 820
- EU EudraLex Volume 4 (Annex 11 and Chapter 4)
- GAMP 5 and risk-based validation approaches
- ALCOA+ principles and data integrity frameworks
- Technical Background: Strong IT/technical background with the ability to understand the complexities of networked programs and infrastructure.
- Familiarity with laboratory, manufacturing, and quality management systems for GMP operations, including:
- Electronic Document Management Systems (EDMS)
- Learning Management Systems (LMS)
- Laboratory Information Management Systems (LIMS)
- Manufacturing Execution Systems (MES)
- Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.
- Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).
- Exceptional written and verbal communication skills, with the ability to author and revise SOPs, work instructions, and validation documents.
- Strong attention to detail and ability to manage multiple projects simultaneously in a fluid, dynamic, and fast-paced environment.
- Proven ability to work independently, within prescribed guidelines, or as part of a collaborative team.
- Collaborative attitude with the ability to manage complex cross-functional projects.
- Experience developing training materials and delivering training to employees on CSV topics.
- Ability to lift up to 20 pounds as needed.
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
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