Are you ready to make a direct impact on the production of life-changing biotherapeutic medicines? At J&J Innovative Medicine in Leiden, you will apply your process validation expertise within a rapidly growing, innovative biopharmaceutical environment?
As an Engineer MSAT Validation within the Supporting Process Validation (SPV) team, you play a key role in ensuring the quality and safety of essential supporting processes. Your focus spans mixing validation, microbial and buffer hold times, and moist heat sterilization. You plan, coordinate, and author critical validation documents including protocols and reports while executing performance qualification activities to support the site change control program. In this role, you elevate operational quality, ensure strict compliance with GMP standards and ALCOA+ data integrity principles, and drive continuous process improvements. Every project step you execute contributes directly to advancing global patient health.
Functie-eisen
- A master’s degree in (Bio)Chemical Engineering, Biotechnology, or a related discipline with 0–2 years of relevant experience, or a bachelor’s degree with at least 2 years of relevant experience in the (bio)pharmaceutical industry.
- Practical knowledge of process validation and qualification (moist heat sterilization, mixing, buffer, and microbial hold times) alongside relevant regulatory standards (FDA, EMA, ISO, ICH, ISPE, PDA).
- Proven experience working in a GMP environment while applying ALCOA+ data integrity principles.
- Strong communication and documentation skills with full proficiency in English (Dutch proficiency is a plus).
- Continuous improvement experience, such as Lean or 6-Sigma methodologies, is preferred
Competenties
In this role, you navigate complex regulatory environments with precision, structure, and strong ownership. You combine risk management skills with analytical problem-solving abilities to resolve root causes effectively. Your clear, proactive communication ensures seamless collaboration and timely status updates across cross-functional project teams. You manage project deadlines with ease, foster knowledge sharing, and drive ongoing process standardization
Arbeidsvoorwaarden
- A contract for a year of 32 or 40 hours per week
- A monthly project allowance 4% of your salary
- 25 holiday days.
- 8% Holiday Pay
- A travel allowance
- A good pension scheme
- Extra allowances for a home workplace budget
- A training budget, coaching, an onboarding program, and unlimited access to the Randstad Academy with over 3,000 courses and trainings
- Networking events and knowledge sessions,
- Work from home possible for 3 days when working 40h. When working 32h it will be less.
Bedrijfsinformatie
J&J Innovative Medicine, part of the Johnson & Johnson Family of Companies, is a global leader in biotherapeutics. The Leiden facility is dedicated to producing high-quality biotherapeutic drug substances and continues to expand its clinical and commercial product portfolio. Within this facility, the Manufacturing Science & Technology (MSAT) department serves as the driving force behind process validation, technical ownership, and state-of-the-art technologies. Working here means advancing your career in an inspiring, professional environment guided by a clear mission and strong corporate values (Our Credo)
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 Randstad Professional. Heb jij een uniek talent? We ontmoeten je graag.