Engineering Project Manager

Job Summary (Primary function)
The Manager Project Engineering is responsible for the overall supervision of the CAPEX definition and management, Engineering process studies. Responsible to supply equipment required for manufacturing in his scope from URS to OQ completion and handover to final user.
The responsibilities will include supporting the design development, procurement, factory acceptance testing, installation, commissioning and qualification of new process systems and equipment used in the production of biopharmaceutical drug substance during the construction phase and then when the site will be validated.

Essential Functions of the Job (Key responsibilities)

• Define CAPEX envelop for Yverdon Manufacturing Plant in collaboration with head of departments and ENG Associate Director.
• Manage Capital Project Execution from Initiation to closure.
• Provide required reporting to ENG Associate Director.
• Direct Management and ownership of design and construction projects to conclusion and handover.
• Provide leadership to engage the project team in order to:
  • Make sure project team is structured to deliver the projects in time, budget and quality.
  • Define clear project structure, R&R within the project team.
  • Ensure project execution is assessed defined preventive measures are implemented in order to avoid any impact on on-going site activities.
• Perform a key role in planning, budgeting and identification of resources needed for CAPEX project implementation and process engineering projects.
• Write project plans and scopes of work.
• Communicate effectively with sub-contractors and Incyte involved collaborators in projects.
• Create and maintain required ENG standards.
• Prepare appropriate project documentation & hand-over.
• Lead and contribute to Risk analysis related to the process systems and equipment.
• Investigate problems and diagnose and repair faults.
• Ensure that commissioning and qualification activities are performed according to GEP, GMP, GAMP respecting current technical, environmental and safety norms as well as following internal standards and Company guidelines.
• ENG Associate Director deputy in case of absence.
• Provide support during Health Authorities inspection by presenting commissioning and qualification dossiers.
• Being the interface and glue between discipline engineers in order to define full scope and deliver end to end project. Provide, when needed, equipment installation, construction and commissioning oversight, including equipment inspections, factory acceptance testing (FAT), site acceptance testing (SAT), and field verification. Ensure effective execution of equipment and system walk-downs with a strong adherence to Safety standards and practices.
• Interface with stakeholders on the Project to ensure the design, execution, and delivery are in accordance with Global Engineering, Quality, Environmental, and Safety procedures.
• When needed, provide input into the development of tools, practices, skills and behaviors that align with the overall project.
• Know about the policy of security at work and about laws concerning health and security of the workers.
• Provide training to maintenance and operative staff where appropriate.
• Contribute positively to a strong culture of business integrity and ethics.
• Act within compliance and legal requirements as well as within company guidelines.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing, Biotechnology, Mechanical Engineering.
• Experience in the biotechnology/pharmaceutical production.
• Excellent written and verbal skills.
• Travelling up to 10%.
• Must have demonstrated capability to provide engineering technical support for GMP facilities including cell culture.
• Experience in engineering, construction, commissioning and validation in a GMP biotech manufacturing environment, or an equivalent combination of education and experience.
• Knowledge of process automation and manufacturing execution systems.
• Must have at least 10 years manufacturing experience in a BioPharmaceutical company.
• Broad knowledge of Pharmaceutical Quality, Manufacturing and GLP/GCP/GMP practices.
• Ability to build trust and create collaborative environment and relationships.
• Strategic thinker who can balance near term objectives with long term goals and outcomes, evaluate risk and develop effective solutions through an integrated multi-disciplined decision-making approach.
• French and English (good oral and written skills).

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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