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Environmental Monitoring & Logistic Expert (m/f)

November 22nd 2019

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

Responsabilities

The Environmental Monitoring & Logistic Expert :

  • Generates (responsible) and/or ensures finalization (accountable/owner) and/or approves generic and transversal documentation as policies/procedures/instructions/forms/protocols which could be eventually approved by Supervisor and relevant stakeholder;
  • Established URS of EM and logistic tools to insure a more efficient EMS and logistic process, and guarantees implementation of such tools in production, in collaboration with other department;
  • Ensures adequate training process concerning EM, cleaning and production logistic;
  • Creates and delivers specific EM, cleaning and production logistic trainings;
  • Is a certified trainer;
  • Is qualified for Gowning grade A/B;
  • Plans and guarantees realization of grades D + C EM & cleaning;
  • Plans, in partnership with production teams, and guarantees realization of grades B/A major cleaning (monthly, quarterly, yearly);
  • Checks EM & cleaning conformities and respect of frequencies for all grades;
  • Manages Environmental grade C/D Dev & CAPA ;
  • Double-checks daily EMS reports for grade D + C;
  • Analyses EM trends and takes actions for parts under her/his scope;
  • Plans and assists in room & projects intercampaigns, completes documentation;
  • Coordinates and guarantees VHP realization, reviews reports. Participates in VHP run realization;
  • Is the production team member at the interface with ERP for “purchases” and “manufacturing” activities and is the production purchases referent;
  • Centralizes production orders (RMC) from project representatives and do purchases;
  • Ensures efficient material transfer until classified rooms (grade D or C) and generic consumables stock level in common rooms;
  • Is the interface for classified rooms logistic with the Technical Service/MERP;
  • Is the interface for classified rooms EM with the Quality Control;
  • Ensures dispatching and collecting controlled quality system documents in classified rooms;
  • Warns immediately the Management in case of  problem or failure;
  • Respects EHS rules in working area;
  • Ensures sufficient back-up for activities under his/her responsibilities;
  • Benchmarked best practices from external companies;
  • Ensures continuous improvement in her/his field and beyond, in particular in establishing/compiling KPI.

Qualifications & Experience

  • Master degree in life sciences, biology, pharmacy, clinical chemistry, bioengineering or relevant experience in a similar position in the sector of Biotech/Pharma/Cell therapy. 
  • At least 2 years of experience in:
    • GMP environment and
    • Aseptic production

Quality

  • For his/her direct responsibility, ensures cGMP implementation through MTC’s quality system and feeds continuous quality improvement;
  • Is involved in preparation and execution of any audits/inspection;
  • Supports change control preparation;
  • Finalizes Deviations (Owner role) and CAPA for hierarchy approval. When transversal  (on top of the specific field) actions to close Deviations or CAPA are identified,  the expert is able to evaluate impacts across MTC on top of its own responsibility field;
  • Is trained for requiring realized activities;
  • EM & Logistic Expert manages Production Supports in Shared Service: ensures adequate repartition of work for production supports, being aligned with Shared Service supervisor and other Shared Service Experts.

Candidate profile

  • Fluency in French and good reading comprehension and writing skills in English;
  • Good Computer skills including  Microsoft office (Outlook, Word, Excel, PowerPoint), ERP system, “ready-to-learn IT user”;
  • Team management abilities;
  • Demonstrated cross functional team spirit;
  • Good communicator;
  • Scientific and methodical approach based;
  • Quality minded, rigorous, customer oriented and continuous improvement driven;
  • Organization skills, multitasking, flexibility and autonomous;
  • Pedagogical abilities

 

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

Click on this link to apply : http://bit.ly/32PVYhX