Experienced Scientist Empower

Johnson & Johnson Johnson & Johnson · Pharma · Ringaskiddy, Cork, Ireland

Experienced Scientist (Empower) role supporting Biotherapeutics R&D development programs and analytical development activities in TDS AD Cork Separation Sciences. Responsibilities include Empower systems support, troubleshooting, custom field development, report method design, data handling, technical support for investigations, strategy document authoring, validation support for lab equipment, and participation in laboratory investigations. The role also involves supporting biotherapeutic R&D projects, method transfer and validation, non-conformance initiation, writing/reviewing lab documents, and coaching junior colleagues. Requires a Bachelor's/Master's degree in a scientific discipline, minimum 5 years of Empower software experience, and knowledge of regulatory requirements (FDA, EMA) in a GMP/cGMP laboratory environment.

What you'd actually do

  1. Day to day Empower systems support and troubleshooting, ensuring that E-tickets are addressed in a timely manner
  2. Build, Design, and release of "Empower" report methods/projects and software updates
  3. Handle and control Separations data (reference materials, Samples) within "Empower"
  4. Providing technical support for Investigations and data requests as the need arises
  5. Supporting the execution of Biotherapeutics R&D projects and development programs as a developing individual contributor

Skills

Required

  • Bachelor's, Master's, or advanced degree in a scientific or technical discipline
  • Minimum of 5 year’s experience of using Empower Software
  • Experience with Change Management systems
  • Knowledge of FDA, EMA, and other applicable regulatory requirements relevant to biologics and/or pharmaceuticals
  • Experience in GMP or cGMP laboratory environments, including analytical testing, method transfer and validation
  • Demonstrated knowledge of scientific theories, principles, and techniques used in biological or pharmaceutical analytical test procedures
  • Strong written and verbal communication skills
  • Ability to work effectively across functions

Nice to have

  • Development/ Administrative experience with Empower software
  • Experience performing progressively advanced responsibilities at Scientist level
  • Acute attention to detail with focus on Data Integrity
  • Familiarity with regulatory requirements for E-Systems and Separations technology (HPLC, CSDS, CIEF, UPLC)
  • Experience supporting non-conformances, investigations, deviations, and CAPA activities

What the JD emphasized

  • Experience performing progressively advanced responsibilities at Scientist level is preferred
  • Knowledge of FDA, EMA, and other applicable regulatory requirements relevant to biologics and/or pharmaceuticals is required
  • Experience in GMP or cGMP laboratory environments, including analytical testing, method transfer and validation is required
  • Demonstrated knowledge of scientific theories, principles, and techniques used in biological or pharmaceutical analytical test procedures is required
  • Strong written and verbal communication skills and the ability to work effectively across functions are required