Empower Automation Specialist
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Empower Automation Specialist in de QC-labs van Janssen Biologics (J&J) via Randstad, hybride Leiden, 40 u/week, 1 jaar.
- Locatie
- Leiden
- Werkvorm
- hybride
- Uren
- 40 uur per week
- Contractvorm
- detachering
- Gepubliceerd
- Opdrachtgever
- Johnson & Johnson
Eisen
- Extensive experience with Empower in a GxP environment, specifically with Custom Field development and validation (both front-end and back-end).
- A minimum of 1-2 years of relevant experience in the pharmaceutical industry with GMP and automation responsibilities.
- Hands-on experience in software development and validation
- Technical knowledge of system/server infrastructure.
- Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent experience.
- Excellent written and verbal English communication skills.
- Proactive ability to work independently, take initiative, and produce protocols, reports, and procedures.
- Strong grasp of GMP standards, 21 CFR Part 11, and general inspection requirements.
- Experience with one or more of the following systems: SoftMax Pro, SDMS, Deskman, LIMS, 32 Karat, or Comet.
- Familiarity with GAMP 5, Computer System Validation (CSV), and Lean or Six Sigma methodologies.
- Deep understanding of laboratory processes, specifically HPLC, analytical calculations, integrations, and the use of reference materials.
- Highly flexible with a willingness to travel between locations (Leiden, Sassenheim, and Schiphol) as required.
Wensen
- Laboratory experience
- Dutch language skills
Omschrijving
This position within the QC Laboratories at Janssen Biologics B.V. offers an exciting opportunity for an ambitious Automation Specialist. You will act as the Subject Matter Expert for automation topics, supporting test laboratories by managing and validating Empower-based methods to ensure seamless data integration, data integrity, and strict GMP compliance. You will deliver and build automated methods in Empower and provide documented evidence that systems are working as intended to support the global organization and LEAN initiatives. This will involve leading the technical implementation of new Empower projects in collaboration with cross-functional teams, implementing and maintaining Empower solutions, creating and maintaining procedures, owning data integrity practices, providing lab instrument support, ensuring software implementations meet 21 CFR Part 11 and GMP standards, performing software validation (IQ, OQ, PQ), and extracting data and graphs from test methods. We are looking for a self-starter with a strong analytical mindset, a sharp eye for detail, and excellent communication skills. You will also bring a Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent experience, a minimum of 1-2 years of relevant experience in the pharmaceutical industry with GMP and automation, extensive experience with Empower in a GxP environment, deep understanding of laboratory processes, strong grasp of GMP standards and 21 CFR Part 11, flexibility to travel between Leiden, Sassenheim, and Schiphol, excellent English communication skills, hands-on experience in software development and validation, technical knowledge of system/server infrastructure, proactive ability to work independently, experience with systems like SoftMax Pro, SDMS, Deskman, LIMS, 32 Karat, or Comet, familiarity with GAMP 5, CSV, and Lean or Six Sigma. Dutch language skills are desirable. The role offers a very competitive hourly rate. This contract will run for 1 year.
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