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We are searching for the best talent for Site Project Execution Lead to be in Puebla - Mexico.

Purpose: Responsible for providing support in the implementation of projects derived from the needs of the different areas of the site, complying with international, local and corporate standards and regulations, as well as carrying out qualifications of critical equipment, areas and systems. Responsible for generating/reviewing and managing the master qualification plan for critical plant equipment, areas and systems and providing support to qualification engineers, as well as developing the required documentation to support start-up (commissioning) activities and qualification, including execution of protocols and generation of reports.

You will be responsible for:

• Attend and manage the needs of our external and commercial clients to strengthen the commercial relationship with Janssen Puebla corresponding to the maintenance area, ensuring the continuous operation of the manufacturing equipment and compliance with the production plan with the corresponding delivery of products to our customers.
• Coordinate the different teams and stakeholders, maintaining clear and effective communication to provide solutions and expedite decision making when required.
• Identify and manage possible roadblocks and/or challenges that may arise during the operational process of our clients.
• Provide visibility in scheduled forums through indicators to measure customer satisfaction.
• Be accountable and develop competencies focused on E2E (business vision) with their work teams to ensure knowledge in the area.
• Responsible for managing the CAPEX and OPEX portfolio of the site, monitoring the metrics of compliance with spending objectives in the site's projects aligned with the approved business plan of the year.
• Support to design, coordinate and implement the different types of projects for all areas of the plant, following up with the different areas involved (Purchasing, Safety, Quality, Plant Engineering, etc.) to meet the exact requirement of the client and deliver at the end of the process a project that fully meets the expectations and needs of the client.
• Follow-up/ organize meetings with those responsible for the areas and / or the direct client to give feedback on its progress and ensure that the necessary requirements for its proper execution are met during the course of the project.
• Support to the different areas involved to comply with the qualification process (Validations, Projects, Maintenance, Security, suppliers, etc.), requesting from the beginning of the project the necessary documents to guarantee that they are delivered at the time of the installation of machines or project completion to ensure that they are validated at the time of operation.
• Interact with those responsible for the different areas to collect the necessary information to update plans, identifications of areas, projects, etc., through a scheduled schedule to have greater control of the process, thus ensuring that the requirements are met. they request at each exchange control.
• Support for the scheduling of projects in order to be able to assign delivery times for equipment, facilities and documentation, closely following up with suppliers, Purchasing, Projects, Packaging, etc., to guarantee compliance with these delivery times
• Knowledge of the technical solution proposals, as well as the scope of the offers given by the suppliers in such a way as to guarantee that they understand the scope of the needs raised as well as how the same requirements are also delivered to each of our clients.
• In conjunction with the Staff Engineer and suppliers, review the designs, diagrams, plans, manuals, etc. and with this, approve the manufacture or installation of machinery, tools, formats, processes, etc., considering the client's requirements and the observations of the areas involved to guarantee their adequate operation in the production processes.
• Support to supervise the work carried out by suppliers during the execution of projects, facilities, services and operational tests, in such a way as to guarantee compliance with the requirements indicated for each activity.
• Know the standards of design, quality, safety and hygiene, through the information received by suppliers, courses, manuals, etc. to guarantee compliance in each step of the project and in its delivery.
• Coordinate with project personnel, production or the client that the supplier's training and training of operators is carried out, requesting from the area managers the availability of the operators to guarantee the adequate operation of the equipment or process with skilled workforce at startup.
• Control and manage the documentation (purchase requisitions, quotes, plans, diagrams, minutes, project transfer, etc.) generated by the projects that comply with the SOX and BPM requirements.
• Support to project growth or continuous improvement through meetings with the managers involved to exchange information on the trend and projects of the plant in the short, medium and long term in order to visualize and meet the needs of the plant.
• Ensure that all activities carried out comply with local and international, regulatory and corporate regulations that apply to aspects of safety, environment, hygiene and health. Apply the IT's that correspond to its processes and satisfying the requirements related to regulatory compliance.
• Knowledge of the technical solution proposals, as well as the scope of the offers given by the suppliers in such a way as to support and guarantee that they understand the scope of the needs raised as well as how the same requirements are also delivered to each of our customers
• Know the principles of ethical business conduct and those expressed in the Creed, applying them to their work activities inside and outside the company.
• Develops, executes, and maintains applicable master plans for Qualifications (manufacturing equipment, packaging equipment, critical services / facilities).
• Aligns methodologies and procedures for installation and Qualification (C & Q) activities on site
• Ensures consistent practice with J& J and related industry standards for Commissioning & Qualification throughout the site, while maintaining compliance with regulatory requirements.
• Supports and execute creation of Change Control’s, URS’s, FMEA’s as well as Validation Documents and PQ’s.
• Participates in inspections as well as audits and drives investigations, deviations, corrective and preventive actions towards successful and compliant closure.
• Actively participate as core team member or extended team member for larger projects, initiatives, and corporate programs (JJPS, Automation, Credo, etc.)
• Supports the team in preparation and during regulatory inspections as needed.

Qualifications / Requirements:

• Education: Bachelor of Engineering, Industrial Automation, Electronic Engineer, Information Technology or Related Engineering.
• English language proficiency: Advanced
• Experience: Experience in GMP or GLP regulated environments and a related position is required: A minimum of 2-4 years of experience is required for the platform level. Experience is required in Qualification of critical equipment, areas and systems. delivering innovative engineering and technical solutions in multiple manufacturing environments; Experience required in areas of Services, Maintenance, Equipment and / or Process Engineering / in a GMP product manufacturing plant environment.
• Windows Office / Software: Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required as well as Minitab, "Siemens & Allen Bradley" PLC programs, COGNEX, Autocad, Solidworks, etc.
• People management: Experience in the administration of unionized personnel and engineering staff.
• Knowledge: Knowledge of pharmaceutical technology (Solid, liquid and semi-solid) is preferred, including the design of experiments and statistical analysis.
  • Work under pressure
  • Teamwork
  • Innovative, customer focus, sense of urgency
  • Proactive, ability to organize and manage projects
  • Negotiation, strategic thinking, strong commitment to compliance
  • Resolution of problems of different nature involving judgment and creativity to generate recommendations
  • Decision making with strong impact in other areas consulting some before taking them
  • Qualification Concepts for: Design, installation, operation, and performance.
• Licenses and certifications: knowledge of process excellence tools (Lean, Six Sigma) is preferred. Yellow or Green Belt certification in Lean or Six Sigma is preferred.