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Biocartis

Automation Engineer

Biocartis


Anvers ( > Belgium > Europe)
29/8/2018
job ID 2018057 

Description de fonction

Purpose of the role

The Automation Engineer will give support to the design, engineering, start-up, optimization, maintenance and life cycle management of the automated and semi-automated manufacturing production equipment including automated vision control systems, electronic batch record systems and configuration management.

Accountabilities

- Responsibility for planning, coordination, execution and follow-up of process improvement and qualification activities related to the (semi-)automated manufacturing line, including automated vision control systems and electronic batch record systems.

- Contribution to maintaining and periodically, evaluating the qualification/validation/part 11 status of equipment, systems, products and processes

- Develop a harmonized approach/strategy for design, configuration management and qualification for cartridge manufacturing and all related systems

- Implement and enforce this approach through SOP’s (Standard Operation procedures) and Work instructions

- Maintain a current knowledge of international regulation, guidelines, policies and new evolutions related to Qualification & Validation and automation, including visual inspection systems through courses, conferences, seminars, internal and external benchmarking and literature. Implement this knowledge to maintain and improve the level of qualification and validation (incl part 11)

- Spokesperson during internal and external audits for qualification/validation of Operational equipment (CAR), systems, products and processes and QC equipment


Fonction : Automation Engineer


Compétences : cGMP manufacturing , ISO 13485 , software programming , PLC-controls and programming , SCADA , Servo-motion


Secteur : Medical Devices


Mobilité

  • Anvers ( > Belgium > Europe)
Profil recherché

- A Master degree in technical science, or equivalent by experience;
- At least 5 years or more relevant experience in the pharmaceutical, medical devices or diagnostics industry is highly preferred;
- Familiar with cGMP manufacturing;
- Experience in software programming, PLC-controls and programming, SCADA systems, Servo-motion technology, HMI, process controls and automated vision inspection systems;
- Familiar with ISO 13485 and cGMP manufacturing;
- Process development, manufacturing equipment development and automation experience and expertise;
- Knowledge of IQ/OQ/PQ/qualification;
- Fluency in Dutch and English; any other European language is an asset
- Flexible and self-propelling;
- Good analytical and decision-making skills
- Good communication skills, both spoken and written
- Ability to work under pressure
- A true team player
- PC skills : MS office

Function Type: Full-time
Experience Required: At least 5 years or more relevant experience in the pharmaceutical, medical devices or diagnostics industry is highly preferred.

Specific professional knowledge :
- Familiar with cGMP manufacturing
- Experience in software programming, PLC-controls and programming, SCADA systems, Servo-motion technology, HMI, process controls and automated vision inspection systems
- Familiar with ISO 13485 and cGMP manufacturing
- Process development, manufacturing equipment development and automation experience and expertise.
- Knowledge of IQ/OQ/PQ/qualification.

Education: A Master degree in technical science, or equivalent by experience.

Functional Area: Manufacturing

Travel Percentage: 0%


Langue

  • Anglais
  • Néerlandais
Information de contact


HR@biocartis.com
Belgique









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