Lead Computer Systems Validation (CSV) Engineer

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 escalate 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 (i.e. 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.

The Candidate

• BS.in Engineering, Computer Science, Life Sciences or another related technical discipline with a minimum 6 years of experience within the biopharmaceutical or regulated pharmaceutical industry (previous CDMO experience is a plus).
• Experience in cell therapy, gene therapy, biologics, aseptic manufacturing, CDMO, or other fast-paced GMP manufacturing environments preferred.
• Strong knowledge of computerized system lifecycle management, risk-based validation, data integrity, electronic records/electronic signatures, requirements development, testing strategy, traceability, and validation summary reporting.
• Demonstrated ability to mentor engineers, establish technical strategy, review complex validation documentation, and provide leadership without direct management authority.
• Experience working with Automation/OT and IT infrastructure, including servers, virtual machines, networked systems, data storage, backups, system restoration, disaster recovery, and cybersecurity controls preferred.
• Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
• Working knowledge of 21 CFR Part 11; 21 CFR Parts 210 and 211, including 21 CFR §211.68; EU GMP Annex 11 and Annex 15; FDA data integrity expectations; ICH Q9(R1); ALCOA+ principles; and industry guidance such as ISPE GAMP 5 and ASTM E2500.
• Ability to quickly learn new and novel manufacturing processes supporting new clients
• Able to work in a team setting and independently under minimum supervision
• Familiarity with electronic systems, including developing and producing reports using Smartsheet and Excel
• Requires the ability to produce quality results in a fast-paced environment to meet client deadlines
• Able to communicate effectively orally and written with all levels of personnel and regulatory inspectors

Position Benefits

• Opportunities for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of within the organization
• Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
• 401K strong employer match
• Tuition Reimbursement
• Employee Referral Bonuses
• Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
• Gain experience in the cutting-edge cell therapy space