Systeem Specialist – Farmaceutische Industrie

Function

As a System Specialist – Pharmaceutical Industry, you are part of a multidisciplinary project team focused on digitalisation, automation and operational improvement. You work in close contact with various stakeholders to map their needs and support the development, implementation and validation of computer systems that underpin critical production processes.

• Analysing the needs of various stakeholders and translating them into clear functional system requirements.
• Supporting the development and implementation of digital production systems, such as MES, SAP S/4HANA and other production-related applications.
• Drawing up and maintaining User Requirements, functional specifications and technical documentation.
• Collaborating with system engineers, IT specialists and external suppliers to translate user requirements into practical system solutions.
• Drawing up, reviewing and maintaining test protocols, test reports and qualification documentation.
• Preparing, executing and following up on system tests, including User Acceptance Testing (UAT).
• Supporting validation activities and Change Controls during the implementation of new systems or functionalities.
• Analysing workflows, data flows and interfaces between various digital systems.
• Contributing to the standardisation and optimisation of digital processes and system configurations.
• Working closely with various departments, including production, Quality Assurance, Engineering, IT and Manufacturing Science & Technology.
• Supporting the commissioning of new systems and ensuring a smooth handover to end users.
• Drawing up work instructions and training materials and guiding users in new system applications.
• Acting as the point of contact for assigned systems and independently taking initiative in the face of technical or functional challenges.

Profile

For this role as System Specialist - Pharmaceutical Industry, we are looking for an analytical and communicatively strong professional with an affinity for digitalisation and computer systems. You are someone who takes initiative, is confident in making independent decisions and collaborates effectively with various stakeholders within a technical or scientific environment.

• You hold a bachelor's or master's degree in a scientific or technical field, such as biotechnology, bio-engineering, pharmaceutical sciences, computer science, industrial automation, electromechanics or equivalent.
• A scientific background is a strong asset, but not an absolute requirement.
• You have at least 1.5 years of relevant work experience within a technical, industrial, IT-related or pharmaceutical environment.
• You have a strong affinity with computer systems, digitalisation and software applications.
• Experience with MES systems is a strong asset.
• Knowledge of SAP S/4HANA, PAS-X, Binocs or similar systems is a plus.
• Knowledge of GMP regulations is an advantage, but not a requirement. Training will be provided.
• You have an interest in analysing business processes and translating user needs into functional system requirements.
• Experience in drawing up test protocols, functional specifications or system validation is an asset.
• You possess strong analytical and problem-solving skills.
• You communicate fluently with various stakeholders and are able to convey complex information in a clear manner.
• You are independent, proactive and confident in making decisions.
• You work in a structured, accurate and quality-conscious manner.
• You feel at home in a multidisciplinary environment and can easily handle changing priorities.
• A good knowledge of Dutch is an absolute must. In addition, you are able to express yourself professionally in English.

Organisation

You will join a specialised consultancy organisation that is active within the pharmaceutical, biotechnological and life sciences sector. The organisation supports leading companies in complex scientific and technical projects, with particular attention to digitalisation, automation, quality assurance and process optimisation.

As a System Specialist - Pharmaceutical Industry, you will be deployed at an innovative biotechnological production environment in Zwijnaarde, where advanced cell and gene therapies are developed and produced. You will contribute to the further digitalisation of production processes and the implementation of systems that play an important role in the efficiency, quality and reliability of production.

The organisation offers its employees the security of a permanent contract, combined with challenging consultancy projects, personal guidance and extensive training opportunities. Even if you have no prior experience with GMP regulations, you will have the opportunity to follow a training course before starting the project.

Offer

As a System Specialist - Pharmaceutical Industry, you can count on an attractive salary package, supplemented by extensive fringe benefits. In addition, the organisation actively invests in your professional development and you will have the opportunity to gain experience within an innovative pharmaceutical and biotechnological environment.

• Permanent contract from day one.
• Gross monthly salary between € 2,500 and € 3,200, depending on your experience and expertise.
• Premium company car with fuel or charging card.
• Net expense allowance.
• Meal vouchers of €8 per day worked.
• Hospitalisation insurance.
• Group insurance.
• Eco-vouchers worth €250 a year.
• 40-hour week with 12 ADV days.
• Training and certification opportunities in digitalisation, automation and GMP systems.
• GMP training at the employer's expense, should you not yet have knowledge in this area.
• Personal guidance and support throughout your professional development.
• Career growth opportunities within the pharmaceutical and biotechnological sector.
• The possibility to collaborate with experts in production, Engineering, IT and Quality Assurance.
• The opportunity to actively contribute to the implementation of innovative digital production systems.