C&Q engineer – Formulation

December 12, 2023
Application ends: March 12, 2024

Apply for this job

Email *
Full Name *
industry *
Browse

Upload file .pdf, .doc, .docx

Job Description

About The Role:

  • Project Background:
    • A major pharmaceutical company is investing into a new aseptic cartridge filling capacity in an existing site. This project includes a high-speed filling line, two formulation skids, two components processor, one dispensing isolator, infrastructure and utilities modifications.
    • This role will be expected to develop and execute C&Q documentation for the project. The overall project will be expected cover a duration of 24-36 months.
  • C&Q Delivery Background:
    • The project will be implementing a Verification methodology (ASTM E2500 Model) to Commissioning & Qualification delivery, the approach applies the principles of right people, for the right activity, at the right time The approach is therefore not a commissioning effort followed by a qualification effort but an integrated and efficient C&Q Program throughout the project lifecycle, from the project design phase through to closeout and handover of systems for operational use. The C&Q program is defined in the Project Verification Plan and a series of guideline documents, with accompanying templates per deliverable. These elements are expected to be in place for use, along with all generated/executed test cases from the existing site projects to use as starting examples for generation. KNEAT software will be used for the project.
  • Role General presentation:
    • The C&Q engineer (Formulation platform) will be in charge for Commissioning & Qualification execution of Formulation platform composed of Sterile Filtration Line, Formulation Tank Station and fixed Sterile tanks.
    • As first mission, he will develop and write all Commissioning & Qualification protocols for the package that he will be assigned, and he will make sure that all documents are reviewed and approved in time.
    • In the second time, he will coordinate, execute, and complete Commissioning & Qualification that shall be perform from initial testing during FAT until final Qualification acceptance of concerned package.

Responsibilities:

  • Perform C&Q in accordance with GFD procedures, best practices, specifications, and project planning documents.
  • Preparation of documents associated with C&Q activities.
  • Preparation and execution of FAT, and SAT protocols
  • Review equipment specifications to ensure FAT, SAT and PIM requirements are included, as appropriate.
  • Preparation and execution of Qualification protocols (IQ,OQ, PQ)
  • Design Qualification (DQ) protocol preparation, execution, and follow-up
  • Field Walkdowns of systems as part of transfer of ownership of the system from Construction
  • Ensuring safe operation of the system prior to and during start-up functional testing and Qualification phases
  • Nonconformity management during project lifecycle
  • Summary Report writing
  • Organize and review daily tasks/verifications and track the progress of the activities assigned.
  • Contractors and/or Vendors coordination
  • Interfacing with representatives on project team, Construction, Engineering, Automation, Quality and End Users during the different project phases.
  • Collaborate with Automation contractors in support of integrated C&Q/CSV approach.
  • Provide weekly status updates to C&Q Formulation Lead

Candidate Requirements:

  • Hard Skills Requirements:
    • BS Engineering (or equivalent experience)
    • 5 years working in pharmaceutical environment and if possible, in sterile process.
    • Minimum 5 years C&Q experience
    • One significant experience in Qualification of formulation package or equivalent equipment
    • Good knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
    • Good writen and verbal communication skills with both technical and non-technical staff (French+English)
    • KNEAT knowledge is a plus for the position.
  • Soft skills requirement:
    • Demonstrated leadership and people management skills.
    • Ability to communicate clearly in an engaging manner with colleagues of various levels of experience.
    • Comfortable working in a matrix environment, convincing others.
    • Strong Analytical and problem-solving skills
    • Ability to work in a fast-paced environment.
    • Ability to work independently and as part of a team