Lead Computer Systems Validation (CSV) Engineer (W)

Cellipont; Research Forest (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Cellipont in Texas is seeking a Lead CSV Engineer to lead and execute CSV strategies for GMP computerized systems. The role will involve collaborating with various teams to ensure compliance with regulatory standards and to support the timely release of systems.

Ideal candidates will possess extensive knowledge of compliance requirements and have a proven track record in computerized systems validation. This is an exciting opportunity to make a significant impact in Cellipont's mission of transforming client discoveries into patient cures.

Qualifications

• Extensive knowledge of 21 CFR Part 11 and EU Annex 11 compliance.
• Experience in computerized systems validation for GMP environments.
• Ability to develop risk-based validation approaches.

Responsibilities

• Lead CSV strategy for GMP computerized systems.
• Collaborate with cross-functional teams for project support.
• Define and execute testing strategies for implementations and upgrades.

Skills

CSV strategy and execution

Risk assessment

Data integrity

Cross-functional collaboration

Job description

Developing and Manufacturing your Cell Therapies from Benchtop to Bedside.

Job Summary

Cellipont Bioservices is growing, and we are looking for a Lead CSV Engineer who believes in the potential of bridging client’s discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.

The Lead CSV Engineer will lead the development and execution of risk-based CSV strategies for new system implementations, software upgrades, configuration changes, remediation activities, and lifecycle maintenance. This individual will be responsible for coordinate and oversee CSV deliverables, including system assessments, user requirements, risk assessments, data integrity and electronic records/electronic signatures assessments, configuration specifications, validation protocols, traceability matrices, and validation summary reports.

The Lead CSV Engineer will ensure computerized systems are implemented, maintained, and modified in compliance with internal procedures, client requirements, and applicable regulatory expectations, including 21 CFR Part 11, EU Annex 11, data integrity principles, and risk-based validation practices. This individual will work closely with Validation, Quality Assurance, Facilities & Engineering, Automation/OT, IT, Manufacturing, MSAT, Quality Control, clients, and vendors to manage project deliverables, resolve technical issues, assess risk, support timely system release, and provide technical guidance to developing engineers and cross-functional teams.

The Role

• Primary responsibility is to lead CSV strategy and execution for GMP computerized systems supporting manufacturing, laboratory, facilities, automation, quality, and supporting infrastructure.
• Serve as the CSV subject matter expert for assigned systems, capital projects, client programs, change controls, investigations, and remediation activities.
• Collaborates cross-functionally with Quality Assurance, Facilities & Engineering, Automation/OT, IT, Manufacturing, MSAT, Quality Control, clients, and vendors to coordinate project activities, resolve issues, and support timely release of computerized systems.
• Develop risk-based validation approaches based on intended use, system complexity, patient safety, product quality, data integrity, and electronic record/electronic signature requirements.
• Define and execute appropriate testing strategies for new implementations, software upgrades, configuration changes, interfaces, data migrations, backup/restore activities, access controls, audit trails, and disaster recovery activities.
• Partner with Automation/OT and IT to assess system architecture, data flows, interfaces, user access, audit trails, infrastructure controls, backup and recovery, and cybersecurity considerations.
• Identify compliance risks and e... (content truncated for brevity)