Intern assisting in packaging development for major food industry company. Contributing to compliance analysis and audits while collaborating with engineering teams.
About the role
- Ensure IT compliance of GxP systems and supporting processes
- Partner with business stakeholders to maintain GxP systems in a validated state
- Select, develop, validate and maintain enterprise GxP systems and supporting infrastructure (including Benchling, Clinisys, Wellsky, Kneat, Ellab, Blue Mountain RAM)
- Act as IT system owner: define and document critical business processes and requirements
- Prioritize requests, create business cases, and manage through IT governance
- Drive planning, implementation, validation and support of enterprise GxP applications
- Establish and drive governance processes for GxP IT projects and operations
- Collaborate with Nestlé IT and business leadership to develop technology strategy, budget, and roadmap
- Serve as Project Manager for technology implementations and coordinate external vendors
- Manage vendor and external service provider relationships and escalations
- Support Clinical Operations, Biometrics and data management systems to ensure GxP compliance
- Oversee application lifecycles, change control, testing, validation, and communication
- Partner with QA to manage systems validation, periodic reviews, and vendor coordination
- Lead/support deviation/incident investigations and implement CAPA
- Support external/internal audits and inspections as needed
- Develop IT support metrics, continuous improvement processes and project documentation
- Ensure compliance with SOPs, WIs, documentation standards and regulatory best practices
Requirements
- BS degree in computer science, information technology or equivalent work experience
- 7+ years of experience supporting enterprise GxP IT systems
- IT biotech project management experience in a multinational environment
- Deep understanding of biotech/pharmaceutical manufacturing systems and processes (drug safety, pharmacovigilance, manufacturing, engineering automation, regulatory compliance, quality management, medical information, clinical trials)
- IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements and clinical operations
- Knowledge of systems software, operations, capacity management, mid-range servers, PCs, SaaS, and web services
- Hands-on experience qualifying production servers to meet regulatory requirements
- Knowledge and expertise with SaaS systems, automated process equipment, and clinical data management software
- Experience with Benchling, Clinisys, Wellsky, Kneat, Ellab, Blue Mountain RAM, Veeva, QMS and QDocs
- Experience in risk assessments, remediation plans, CAPA, and reviewing/modifying/writing SOPs
- Experience with technical documentation (VP, IQ, OQ, Test Protocols, Summary reports)
- Solid applied knowledge of 21 CFR Part 11, Part 820, Annex 11, GAMP 5, CSA, and Data Integrity
- Experience with CSA transformation a plus
- Experience managing change control processes
- Excellent communication skills and ability to interface and influence at all levels
- Detail-oriented with strong analytical, organizational, and problem-solving skills
- Ability to troubleshoot, research, and solve technically challenging problems involving integrated systems
- Strong customer service orientation and understanding of pharmaceutical and dietary supplement manufacturing business processes
- Occasional travel required (about 10%)
- This position is not eligible for Visa Sponsorship
Benefits
- Performance-based incentives
- 401k with company match
- Healthcare coverage
- Competitive total rewards package and a broad range of other benefits
- Benefits that support physical, financial, and emotional wellbeing
- Dynamic career paths and robust development opportunities
- Opportunities to learn from talented colleagues around the globe
- Incentives and/or benefit packages may vary depending on the position
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
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