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MSAT Engineer Knowledge Management (H/F/X)

June 23rd 2021

Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

The Role

The MSAT Engineer Knowledge Management reports to the Head of department.

The MSAT Engineer's main role is to lead the transfer and validation of  process & analytical methods ensuring a proactive vision of the strategy to be used across different projects and activities.

This will lead to an effective cGMP status for the validation and effective Tech Transfer from P&AD or from the customer.

The Engineer will also act as a referent either within the team, the company and customer.

She/He  will also play a significant role within the New Technology, Knowledge management or Site Support.

The Role

The MSAT Engineer is an active member of the department management team

Promote and ensure productive communication between team and management

Contribute to define end deploy a strategy to deliver a Process History File able to capitalize on the process & analytical knowledge acquired along project

Contribute to establish and deliver comprehensive scientific and technical training package for other department like manufacturing or QC, Active contributor to C&GT academy on site, first intend

Work closely with S&T to implement a continued process verification process intended to master the process and analytical method intended to end up with a more efficient process and testing

Coordinate and promote continuous improvement activities associated to MSAT, as for broader company analytical and process projects

Aligned with Commercialization dpt, Manufacturing, QC or P&AD will work on technical solution to meet business objectives.

Determines the impacts of a project scope change on resources and timelines of his/her project(s) and then reports his/her conclusions to responsible people

Candidate profile

The Candidate

5 years of experience in a cGMP biopharmaceutical environment.

Or Proven experience in Process and analytical methods validation and statistics, tech transfer

Experience in cell therapy or quality control of cells from human tissue origin is a plus

Experience in biopharma environment and Inspection readiness at the highest level ( FDA or equivalent) is a must.

Fluency in French and Excellent written and spoken English (At least level B2 required)

Confirmed team player, Efficient communicator and demonstrate diplomatic skills

Demonstrated leadership and assertiveness, Demonstrates initiative and ability to meet deadlines

Ability to manage discussion with clients/Project Leader

Hands-on mentality

Quality-oriented, rigorous

Patient and customer-oriented

Offer

Position Benefits

Full-time position (40h/week)

An indeterminate contract

The opportunity to take part in a growing dynamic biotech company

A human-sized working environment with a convivial atmosphere

Attractive salary packing including additional benefits

Contact Details

To apply for this job, please send your application on the following link : catalent