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TS – Tehnical Leader CSV (M/F)

February 24th 2020

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission 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, MaSTherCell’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

The CSV Technical Leader main role is to :
•    Be the Single Point Of Contact for any CSV related question.
•    Advice users, as well as clients representative when new computerized system are installed.
•    Coordinates activities with the help of users, IT and QA department.
•    Translate user’s needs into technical solutions, taking into account QA requirements, as well as IT technical constraints.
•    Ensure first line troubleshooting and support on CSV day to day activities.
•    Manage improvement/modifications to be performed on computerized systems, in close collaboration with users, QA and IT departments.
•    Ensure a techno-vigilance into his field of competencies.
RESPONSABILITIES
•    Technical expertise:
He/she is the Subject Matter Expert covering technical questions into his field of competencies (electronic data management, equipment qualification, data integrity, …).
•    Communication:
He/she is the interface between the Technical Service department and all other MaSTherCell’s departments or customer for technical aspects related to projects he/she is leading.
He/she warns the Technical Service Supervisor / Manager in case of issue.
•    Planning management:
He/she manages the action log related to CSV activities he/she is leading and respects the timelines.
Organizes and manages regular meetings to ensure the follow-up of all tasks linked to CSV activities.
Ensures respect of KPI.
•    Quality:
For his/her direct responsibility, he/she ensures cGMP implementation through MTC’s quality system and feeds continuous quality improvement.
Supports change control preparation.
He/She Initiates and finalizes Deviations (Owner role) and CAPA for hierarchy approval.
He/She is trained for required activities and is providing data for relevant KPI.

•    Trends & continuous improvement:
He/she implements and follows-up Key Performance Indicators.
He/she implement pertinent tools of operational excellence “Lean culture”.

Candidate profile

OBLIGATORY REQUIREMENTS

  • Master/Engineer in Science, electro-mechanical or equivalent by experience.
  • At least 4 years experience in pharmaceutical field: ie 21CFR Part 11/ equipment qualification / technical support / maintenance /validation / clean room / equipment management.
  • Minimum 4 years experience in CSV.
  • Fluency in French & English.
  • Good reading comprehension and writing skills in English.

RELEVANT REQUIREMENTS

  • Computer skills: Microsoft office, expertise with GMAO tools database management tool.
  • Efficient communicator and willing to bring new challenges.
  • Demonstrated leadership and cross functional team spirit.
  • Rigorous, conscientious, curious, versatile, open-minded & quality-minded.
  • Customer oriented.
  • Solutions & results oriented.

Offer

  • 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.

Contact Details

Please apply on the following link: MaSTerCell