Associate Director - Computer Systems Validation

Celltrion Branchburg, LLC•Branchburg Township, NJ

3d•$135,000 - $180,000•Hybrid

About The Position

Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics. We are committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. We have been at the forefront of biotherapeutic development uncovering new ways of targeting the drivers of disease by creating next-generation biologics and small molecule products. Celltrion Branchburg, LLC is a subsidiary of Celltrion USA, established in 2025 following Celltrion USA’s acquisition of Eli Lilly’s drug substance (DS) manufacturing facility located in Branchburg. By linking robust local manufacturing capabilities with an existing direct sales network, we aim to generate greater synergies across our operations. Looking ahead, we also anticipate expanding into the contract manufacturing organization (CMO) sector. The leader of Computer System Validation and Computer Software Assurance (CSV/CSA) is responsible for leading and governing all site-wide CSV and CSA activities to ensure that computerized systems are validated, compliant, and maintained in accordance with GMP regulations, 21 CFR Part 11, and global quality standards. This role provides strategic leadership, establishes validation frameworks, and ensures the consistent execution of validation lifecycle activities across all systems supporting manufacturing, facilities/utilities, quality, laboratory, and enterprise functions. This leader serves as the primary liaison between IT and automation, Quality Assurance (QA), system owners, global teams, and vendors, ensuring alignment, inspection readiness, and sustainable compliance.

Requirements

Experience performing qualification of manufacturing automated equipment and computerized systems.
Understanding of FDA and EU regulations and guidelines and knowledgeable of current industry trends.
Have organizational and time management skills that will allow for effective prioritization of activities.
Understanding of key data integrity principles to ensure requirements are aligned to appropriate testing strategies with the use of electronic data / databases.
Have broad knowledge of computer systems and automated process equipment or utility systems, such as Rockwell (PLC/HMI), MES, ERP, and OSI PI Historian to develop qualification protocols meeting user and functional requirements.
Have strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner within a GMP environment.
Strong analytical, problem solving, and excellent interpersonal skills.
Bachelor’s degree in engineering, science, or related discipline with a minimum of 5 years’ experience in cGMP biopharmaceutical manufacturing.

Nice To Haves

Prior leadership experience preferred.

Responsibilities

Lead and develop a high performing, site-wide CSV/CSA team responsible for validation execution, inclusive of resource planning, skill building, training, and inspection readiness.
Define and maintain the site-wide CSV/CSA strategy for information technology (IT) and operational technology (OT) policies and procedures aligned with site, global, and regulatory expectations. This includes adherence to strategies such as validation lifecycle frameworks and risk-based validation approaches. Align IT and OT validation lifecycle approaches.
Maintain and implement an annual technical continuous improvement and asset qualification monitoring (AQM) agenda.
Oversee execution of validation activities across all GMP systems, including: supporting risk assessments based on system criticality and data impact, validation planning and test execution (IQ/OQ/PQ), and traceability / documentation completeness.
Ensure all computerized systems remain in a validated state throughout their lifecycle. Partner with QA to maintain compliance with data integrity, audit trail, and security requirements consistent with regulatory expectations (GAMP 5, EU Annex 11, 21 CFR Part 11, etc.). Lead regulatory inspection readiness for CSV/CSA and support inspection activities.
Ensure effective handover between project and operational phases of computerized systems.
Influence internal and external customers/regulators/partners, including to adopt a different point of view on difficult concepts. Partner with key stakeholders to harmonize validation approaches and incorporate regulatory feedback. Benchmark through industry consortia and conferences.
Provide representation where required for cross-functional and cross-site technical initiatives.
Contribute to the site planning processes (such as business and strategic plan).
Collaborate cross-functionally with manufacturing, automation, engineering, IT and quality teams to align validation scope with system criticality and business impact, ensuring on-time delivery.
Network and engage internal and external expertise to enable the delivery of world class large molecule manufacturing operations to Branchburg.
May be required to travel offsite to other Celltrion or partner sites within the global network, other pharmaceutical companies, conferences, networking events, or off-site training.
Develop strong working relationships cross-functionally to ensure success.
Represent Branchburg on cross-site teams exploring CSV/CSA optimization, best practices, and other technical excellence initiatives.
Provide leadership, training, coaching, and effective career development for team.
Conduct annual performance reviews with team members.
Ensure the company values, standards and policies are communicated to and modeled within the team.
Participate in succession planning.
Perform and champion all work in a safe and compliant manner.
Proactively support site management decisions and strategy.