The Company
The company is a global biotechnology company dedicated to improving the lives of patients. In Breda they focus on preparing, planning, and coordinating the shipping and distribution of clinical trial materials.
Role Description
The position provides technical leadership for the implementation, maintenance, and optimization of Manufacturing Execution Systems (Koerber PAS|X) and their integration with Product Serialization Systems (Systech), ERP (SAP), SCADA platforms, and other automation interfaces. The role supports both commercial and clinical packaging and labeling operations, ensuring systems are compliant, reliable, and aligned with corporate standards. The individual will manage projects, develop solutions, and maintain services critical to site operations.
Responsibilities
- System Management & Support - Overseeing lifecycle management of MES and packaging execution platforms. Handling service requests, incidents, and change management for automation systems. Maintaining system design, configuration specifications, and documentation. Performing configuration, testing, and implementation of system changes.
- Project & Technical Leadership - Leading initiatives related to system upgrades, expansions, and new requirements. Translating business needs into technical solutions and creating project artifacts. Facilitating cross-functional meetings to optimize operations and implement solutions. Mentoring and training team members on systems and processes.
- Compliance & Quality - Ensuring systems comply with GxP, SOX, FDA regulations, and corporate standards. Maintaining SOPs and contributing to policy development for IS systems. Supporting audits and responding to regulatory inquiries.
- Collaboration – Acting as a point of contact for applications and related infrastructure. Promoting communication between business teams, technical staff, and suppliers.
Requirements
- Bachelor’s degree in Computer Science, Information Systems, Engineering, or Life Sciences.
- Minimum 6 years of experience with MES and packaging execution systems in regulated environments.
- Strong knowledge of automation systems, interfaces (OPC), and IS technologies.
- Experience with Koerber PAS|X, Systech Serialization, Rockwell FactoryTalk, and related platforms.
- Familiarity with FDA cGxP, 21 CFR Part 11, and software validation practices.
- Understanding of network fundamentals, data conversion, and system integration.
- Background in biopharmaceutical packaging operations.
- Knowledge of ITIL framework and global pharmaceutical environments.
- Proficiency in Oracle, SQL, Unix/Linux systems.
- Service-oriented mindset with strong organizational and time management skills.
- Excellent analytical, problem-solving, and communication abilities.
- Ability to work independently under minimal supervision and in a team matrix environment.
- Fluent in English; willingness to work on-call outside office hours.
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.