Lead Computer Systems Validation (CSV) Engineer (W)

Cellipont Bioservices • The Woodlands, TX

1d

About The Position

Cellipont Bioservices is seeking a Lead CSV Engineer who is passionate about advancing cell therapies from discovery to patient cures and is driven to challenge the status quo. The Lead CSV Engineer will be responsible for leading the development and execution of risk-based CSV strategies for various system lifecycle activities, including new implementations, upgrades, changes, and remediation. This role involves coordinating and overseeing all CSV deliverables, ensuring compliance with internal procedures, client requirements, and regulatory expectations such as 21 CFR Part 11, EU Annex 11, data integrity principles, and risk-based validation practices. The Lead CSV Engineer will collaborate with multiple departments including Validation, Quality Assurance, Facilities & Engineering, Automation/OT, IT, Manufacturing, MSAT, Quality Control, clients, and vendors to manage projects, resolve issues, assess risks, facilitate system releases, and provide technical guidance.

Requirements

• BS in Engineering, Computer Science, Life Sciences or another related technical discipline.
• Minimum 6 years of experience within the biopharmaceutical or regulated pharmaceutical industry.
• 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.
• 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.

Nice To Haves

• Previous CDMO experience is a plus.
• Experience in cell therapy, gene therapy, biologics, aseptic manufacturing, CDMO, or other fast-paced GMP manufacturing environments preferred.
• 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.

Responsibilities

• 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 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.
• Support and/or lead client on-site audits and participate in on-site technical visits.
• Support regulatory (i.e. FDA, EMA) inspections.
• Maintain 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior