Yacht Life Sciences has a vacancy for a Technical Operations (Associate) Engineer to work at Janssen Biologics in Leiden.
Leiden site Technical Operations (TO) manages the process technology platform strategy for the production of biotherapeutics and vaccines in Leiden. They are responsible for Validation and Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of their commercial production processes!
As a Technical Operations Engineer, you are primarily responsible for the execution of verification and validation activities for supporting processes such as: cleaning, sterilization, mixing and temperature control units.
- Coordinate and execute validation of supporting processes such as cleaning, sterilization, mixing and temperature mapping.
- Write and review validation protocols and reports.
- Connect with operations for timing of execution and communicate status and issues.
- Act as Project Core Team Member for small projects and as such:
- Define validation strategy.
- Represent TO in multidisciplinary team and align with extended team members.
- Plan and deliver team/project Goals and Objectives.
- Act as SME lead for one or more validation sub-categories. Own the training curricula of those categories, ensuring that they are up-to-date and relevant.
- Contribute to global standardization and continuous improvement initiatives for Technical Operations.
- Maintain compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo etc.).
- Bachelor or Master degree in Science, Engineering and/or Technical Subjects
- >2 years of relevant work experience
- Experience of validation. Preferably in the field of large molecule APIs
- Experienced with or good understanding of manufacturing processes (USP/DSP)
- Manufacturing experience within a GMP regulated environment.
- 6-Sigma/Lean or similar problem solving/decision making methodology training (preferred)
- Experience in non-conformance and change control (preferred)
- Excellent interpersonal and communication skills.
Terms of employment
This concerns a direct contract at Janssen Biologics (J&J) for 1 year. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. They will offer a competitive benefit package in line with the seniority of the position (salary between 3000 and 4500 euro gross per month).
About the company
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
Leiden site Technical Operations (TO) manages the process technology platform strategy for the production of biotherapeutics and vaccines. They are responsible for Validation and Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of their commercial production processes!
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.