Role Overview:This role is for an experienced Technical Lead/Architect with deep expertise in Agile PLM, Java, and web application development. The successful candidate will lead a small team, manage application support, and ensure compliance with GxP regulations within a Pharmaceutical/Life Sciences environment.
Key Responsibilities: - Perform as a Technical Lead/Architect and manage a small team (approx. 5 persons).
- Lead and represent the team, demonstrating strong communication skills.
- Manage Application Support, including Incident, Problem Management, Service Requests, and Change Management.
- Handle CAPA, Deviations, User Access Review, and PR processes.
Required Skills: - In-depth knowledge of Agile PLM, specifically PC, PPM, and PQM Modules.
- Strong understanding of PLM Business Processes and experience handling integrations.
- Proficiency in Java, Web application Development, and Web services.
- Experience in the Pharmaceutical/Life Sciences industry with GxP compliance.
- Familiarity with industry-standard quality assurance and control principles (e.g., 21 CFR Part 11, GAMP 5).
- Knowledge of health authority regulations such as FDA, 21 CFR, and MHRA Annex 11.
- Subject Matter Expert in GxP (GDP, GLP, GMP) and Data Integrity.
- Strong issue solving, analysis, and leadership skills.
- Essential skills include Teamcenter Product (PLM).
Qualifications: - 10+ years of relevant experience.
- Java Agile PLM Certification is preferred.
Preferred Skills: - Enhancement experience using Agile SDK.
- Additional knowledge in Oracle PLM Analytics, Neo PLM, and Global Vision.
