This contract is a framework contract for project manager, site manager, operational excellence (OPEX) support services, quality assurance, industrial engineering and industrial designer.

The market is divided into lots as follows:

- lot 1: "Project manager" and "Site manager";

- lot 2 "Quality Assurance" and "Operational Excellence (OPEX)";

- lot 3 "Industrial Engineering (processes, mechanics, electricity, ...)" and "Industrial Designer".

The description of the missions appears in the point "Technical description" for each lot.

Project Manager:

- organize the project team;

- ensuring the interface between the various stakeholders, internal and external (customer, suppliers, partners, authorities);

- organize regular working, progress and coordination meetings, in order to monitor the progress of the various tasks;

- pilot studies (design, feasibility, etc.);

- carry out end-of-contract reviews and feedback;

- define and then regularly check the planning and budget (knowledge of MS Project software is a plus);

- regularly assess the risks and hazards on the project and put in place mitigation actions;

- communicate on the progress of the project, feed the monitoring dashboards and report to the management of the IRE regularly, identifying the risks involved and the problems encountered;

- participate in the establishment of consultation files, analysis of offers, markets and service orders.

Site manager:

The missions during the preparation phase of the works:

- read the market and the schedule;

- take charge of monitoring work execution procedures). Complete the registration document;

- ensure that the inventory is carried out before the start of the work (base living, storage area and work area);

- ensure the implementation of the signage plan, the securing of the site, the provision by the contractor of the work log;

- check that the layout plan of the connections (water, electricity, gas, sewers) is indeed available to those working on the site (contractor and sub-contractors).

The missions during the works execution period:

- ensure compliance with the organizational framework defined in the preparation phase;

- ensure the application of the access rules, concerning class 1 nuclear installations;

- ensure compliance with the security rules defined in the health security plan and the application of internal procedures (work permit, fire permit, etc.);

- ensuring the coordination of all internal (production, security services, etc.) and external (contractor personnel, subcontractor, security coordinator, control office, etc.) stakeholders depending on the activity of the site. Plan and lead daily site preparation meetings;

- supervision of the methods and means of execution to be implemented, so that the site proceeds in the best conditions of security, deadlines and costs (budgetary respect),

- monitor the budget and planning, warn the project manager of potential drifts during the different phases of the project;

- ensure that the work coordination log is regularly completed by the safety coordinator;

- participate in weekly site coordination meetings, read the reports and ensure that any comments or reservations are lifted by the various stakeholders;

- ensure compliance with the calendar objectives and, if necessary, analyze the source of the delays and propose corrective measures to the project manager, to make up for delays,

- ensure that the work log is filled daily;

- streamline the exchange of information with the different departments of the IRE (progress of the site, access plan to the facilities during the site, instructions, work instructions, etc.).

The missions during the assistance operations reception phase:

- in coordination with the project manager, establish the planning of reception operations;

- assist the project manager during reception and reserve lifting operations;

- manage the lifting of reservations ... (see contract documents).

Quality assurance:

- develop, improve and manage quality systems by drafting product quality reviews, ensuring internal audits and supplier audits, ensuring documentation / deviations / change controls / customer complaints / monitoring of suppliers and subcontractors, by providing training, writing or reviewing procedures and operating modes, by establishing and monitoring performance monitoring indicators;

- participate in the definition of the QA strategy, establish a continuous improvement process and provide expertise in terms of training and implementation within the company of standards such as CGMP / ISO 9001 / ISO 13485 / ISO17025. Prepare specific certification or accreditation procedures and ensure the sustainability of current certifications;

- ensure normative and regulatory monitoring, and ensure the writing of risk analysis.

1.2. Qualification & Validation

- Provide support and expertise in the management of qualification activities (analytical equipment, production equipment, computer software, premises and buildings) and validations (analytical methods, manufacturing processes, cleaning). In particular, ensure the drafting of URS, validation plans, risk and impact analyzes, protocols and reports. Ensure the execution of protocols.

1.3. Quality Control

- perform laboratory analyzes on raw materials, production intermediates and finished products (drugs or APIS). Ensure the management and investigation of out-of-trend or out-of-specification results;

- provide expertise and ensure the development and validation of analytical methods for these same products;

- participate in the maintenance, periodic checks and qualification activities of laboratory equipment.

1.4. Regulatory Affairs

- provide support and expertise in the field of regulatory affairs. In particular, ensure the writing of DMFs, ASMF and AMM and associated variations.

Operational excellence (Opex):

- develop, improve and monitor the Opex system;

- train / coach on principles and tools (5S, TPM, problem solving, VSM, etc.);

- ensure the follow-up of the Opex system deployment plan (roadmap, planning, etc.);

- participate in the definition of the communication plan around the Opex system;

- contribute to the Opex monitoring committee;

- deploy performance management;

- deploy visual management;

- deploy a system of standardized meetings and associated animation;

- deploy the 5S approach in workshops and offices;

- deploy a system for collecting and processing improvement ideas;

- deploy a group problem-solving method;

- deploy the TPM approach;

- raise awareness, explain and communicate around Opex; contribute to change management;

- support the overall process of transformation and behavior change;

- help involve teams in continuous improvement;

- identify improvement projects and propose the most relevant methods for carrying out the work;

- monitor improvement projects;

- prepare / draft various documents and supports;

- contribute to the implementation of VSM projects;

- carry out targeted performance diagnostics;

- actively manage performance and measure the progress of projects;

- participate in the collection of data;

- contributing to the development of tools promoting optimization and continuous improvement of processes.

Industrial Engineering (processes, mechanics, electricity, ...):

- ensure the technological and competitive intelligence of the company;

- provide expertise and technical diagnosis;

- study the feasibility of the project according to technical constraints and taking into account budgets and deadlines. Perform pre-analysis and pre-sizing calculations;

- write the technical specifications and define the specifics of the project, in compliance with the quality objectives, cost and deadlines previously defined;

- model and simulate the behavior according to the constraints defined in the specifications;

- ensure product compliance with safety and security standards;

- identify the tools and methods to be implemented during the development phase;

- develop technical files according to client procedure and calculation notes, check their consistency with the client's requirements, communicate them to the project teams and keep them updated according to the progress of the project;

- provide technical support to production teams in the industrialization phase;

- define and carry out product validation tests, and make the necessary corrections;

- analyze user needs and identify areas for product improvement or development;

- advise the project team and recommend improvements based on the objectives set (cost, quality, deadline, technical constraints, mechanical performance, etc.);

- participate in progress and coordination meetings.

Industrial design (building, mechanics, electricity, ...):

Ensure the pre-industrialization / preparation of the prototype:

- study the design in accordance with the standards and regulations in force;

- carry out plans (CAD, CAD);

- draw the overall plan;

- check the feasibility of the parts;

- propose improvements to save time and costs;

- prepare the preparation of the production file;

- participate in monitoring the implementation.