Lead Computer Systems Validation; CSV Engineer; W

Developing and Manufacturing your Cell Therapies from Benchtop to Bedside.

Cellipont Bioservices is growing, and we are looking for a Lead CSV Engineer who believes in the potential of bridging client 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 coordinating and overseeing 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.

• 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.
• Collaborate 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 escape to management with remediation proposal and lead solution implementation.
• Lead CSV impact assessments for change controls and determine required documentation, testing, approvals, and implementation activities.
• Provide technical support for deviations, investigations, CAPAs, audit responses, and system remediation activities involving computerized systems.
• Review validation deliverables and provide technical guidance to junior engineers and cross‑functional teams on CSV expectations, documentation quality, risk‑based decision‑making, and regulatory requirements.
• Support the development and continuous improvement of CSV procedures, templates, work instructions, and lifecycle standards.
• Supports and/or leads client on‑site audits and participates in on‑site technical visits.
• Support regulatory (e.g., FDA, EMA) inspections.
• Maintains systems used for tracking various GMP manufacturing‑associated support activities.
• Generation and/or revise SOP documents following cGMPs.
• Maintain current knowledge of applicable cGMP regulations, regulatory guidance, and industry standards relevant to computerized systems, including FDA and EU requirements, 21 CFR Part 11, EU GMP Annex 11, data integrity principles, ICH guidance, and ISPE GAMP guidance.

• BS in Engineering, Computer Science, Life Sciences or another related technical discipline…