System Manager, Applications and ELN Administration

About the role

Help build the digital backbone of next-generation biopharma. As our System Manager, you will own and elevate core Product Technology platforms—PDLM, ELN, and Risk Management—that power Process Development and MSAT. You’ll translate real-world science into robust, compliant digital solutions, weave data integrity through every workflow, and enable a new, standardized way of working across global teams.

Responsibilities

• Design, configure, implement, and maintain PDLM, ELN, and Risk Management platforms to meet user and compliance requirements
• Translate business needs into scalable, class-based configurations and reusable library objects that enable data standardization
• Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on risk-based validation (GAMP 5, CSA) and audit readiness
• Define and enforce standards, templates, libraries, and master data structures in partnership with Master Data teams
• Deploy class-based data structures to deliver recipe data models and master data (materials, specs, equipment classes)
• Develop training, job aids, and adoption materials; coach teams on ISA-88 and digital recipe best practices
• Manage external partners and solution vendors; define user requirements, participate in design reviews, and ensure delivery to standards and timelines
• Drive harmonization and standard work across sites (templates, test protocols, UAT scripts) to reduce cycle times and deviations
• Champion continuous improvement through metrics, KPIs, and standardized ways of working

Requirements

• Bachelor's Degree in Engineering or Scientific related field
• 5+ years' of relevant experience in Information Technology implementing and sustaining GxP impacted systems in life sciences or closely related industries
• Demonstrated experience with Computer System Validation (CSV) and data integrity principles (ALCOA+)
• Proven experience with one or more: PDLM/PLM, ELN, or Risk Management Platforms

Preferred Requirements

• Experience in manufacturing or process development systems preferred (MES/LIMS/QMS/data platforms)
• Preferred experience in pharmaceutical industry, IT CSV
• Familiarity with ISA-88/ISA-95 standards and digital recipe principles

What you’ll bring

• Deep understanding of PDLM/PLM and ELN platforms and their application to Process Development/MSAT
• Strong knowledge of CSV, data integrity (ALCOA+), and risk-based validation (GAMP 5, CSA)
• Knowledge of ISA-88/ISA-95 and digital recipe principles
• Excellent stakeholder communication and facilitation skills; ability to influence without authority
• Strong problem-solving and analytical skills; experience with KPIs and continuous improvement
• Comfort operating in a global, matrixed environment

Benefits and Compensation

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k)savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays.