Job Summary (Primary function)
During the construction and facility startup phase, the Downstream Production Technician MES will be responsible for authoring, reviewing and testing MES recipes for DSP manufacturing and support. This may include solution preparation, skid cleaning, chromatography, viral inactivation, normal filtration, viral Filtration, UFDF, etc.
During manufacturing operation, the Downstream Production Technician MES will develop in an operations based role.
Essential Functions of the Job (Key responsibilities)
During the construction phase, you will mainly:
• Collect the end user requirements and draft, review User Requirement Specifications for MES
• Actively participate in the creation of the MES platform
• Author Functional Specifications for DSP and support recipes
• Code and review electronic recipes
• Manage MES recipe reviews with various stakeholders (QA, Manufacturing, support)
• Support on the floor MES start up activities
• Create MES user manuals
• Prepare and dispense training to end users
During operational phase, you will mainly:
• Draft, review all required Standard Operating Procedures, Work Instructions, Manufacturing Batch Records, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required
• Support MES related changes
• Raise, investigate and close events, deviations and non-conformances
• MES call-out duty
• Act as an example in the cleanroom to ensure timely batch execution, and proactively propose problem resolution
• Execute batch related activities
• Actively participate in continuous improvement initiatives - proposing and implementing with team
Qualifications (Minimal acceptable level of education, work experience, and competency)
• Biotechnology or pharmaceutical degree preferred or relevant experience from biotech industry
• Demonstrated, hands on experience of DSP manufacturing
• First experience of using an MES system in biotech environment is required (PAS-X preferred)
• Good computer-skills
• Shift work is expected
• Ability to work in a fast paced – high regulated environment
• French and English is a bonus
• Team work oriented mindset
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
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Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.