Within the Analytical Development (AD) department, part of DPDS Therapeutics Development & Supply, multiple teams work on the development of innovative therapeutic solutions. All multidisciplinary pillars are supported by the Lab Operations team. Within this pillar, the Equipment Life Cycle Management (ELM) & Automation team focuses on equipment lifecycle management, data integrity, operational support, and cybersecurity for all laboratory equipment. Due to the continuous growth of the department and the expanding inventory of lab systems, we are looking for a proactive and assertive ELM & Automation Specialist.
Key Responsibilities
In this role, you will act as a vital link between the laboratory floor, IT, Quality Assurance, and external vendors. You will ensure a seamless equipment lifecycle and guarantee that data workflows meet the highest quality, data integrity, and compliance standards (GMP).
- Equipment Lifecycle Management: Support the introduction, qualification/validation, periodic reviews, and decommissioning of laboratory equipment. Coordinate prerequisites for new equipment (such as PCs, docks, network connections) in close collaboration with IT.
- Systems & Automation Support: Maintain and support laboratory data acquisition systems, with a strong focus on Waters Empower (as well as Chromeleon, Unifi, and ICE3).
- Data Integrity & Cybersecurity: Translate user requirements into technical specifications following Data Integrity (DI) standards. Configure basic network and Windows firewall settings in alignment with IT.
- Process Improvement & Reporting: Set up automated reports and custom fields in Empower, and support paperless laboratory initiatives.
- Stakeholder Management: Proactively connect and communicate with lab personnel, the IT department, warehouse/logistics, and external vendors (e.g., Agilent, Waters).
Functie-eisen
- A completed Bachelor’s degree in Life Sciences, Computer Sciences, or an equivalent field.
- Minimum of ~4 years of relevant work experience in a similar role (e.g., Validation Engineer, Lab Automation Specialist, or Equipment Coordinator) within a GxP/GMP-regulated environment.
- Hands-on experience with Waters Empower (Chromatography Data System) is strongly preferred.
- IT & Connectivity: Fundamental knowledge of networks, PC configurations (ports, Windows firewall), and data flows between lab systems.
- Languages: Fluency in English (written and oral) is required. Proficiency in Dutch is highly desirable due to the diversity on the shop floor.
Competenties
- Communication & Assertiveness: Strong interpersonal skills; you easily approach stakeholders at all levels across the organization (from lab technicians to IT engineers and warehouse staff).
- Proactive & Solution-Oriented: A problem-solver who works independently, takes initiative, and can effectively prioritize multiple commitments.
- Analytical mindset with sharp problem-solving skills
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,
- Requires 5 days on-site in Leiden for the first six months, transitioning into the possibility to work 4 days on-site and 1 day working from home thereafter.
Bedrijfsinformatie
The client in Leiden is a global leader in the development and production of innovative vaccines and biological medicines. Within the Engineering, Validation & Maintenance (EVM) department, you will step into a professional environment where collaboration, quality, and safety are paramount. As a consultant through Randstad Professionals, you will have the opportunity to apply your expertise within this high-tech GMP environment. You will work closely with driven domain experts and directly contribute to impactful change initiatives.
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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.