For one of the largest European companies for pharmaceutical contract development and manufacturing, we are hiring a
PHARMACEUTICAL PROJECT ENGINEER
The candidate will be responsible for planning, organizing, and directing all technical activities of the project team to ensure technical success and adherence to the project schedule.
- Develop and review project proposals, feasibility analysis, scope of work, basis of design, project schedule, budgetary estimate, facility utilization, risk analysis and implementation plan.
- Plan, facilitate, and conduct design reviews. Capex project submission for budget approval to the company corporate.
- Develop and review documentation to support implementation of new or existing equipment (User requirement specifications, detailed design review, Operating and Maintenance procedures, FAT, SAT, and commissioning documents.)
- Perform extensive analysis, commissioning, functional testing and start-up for pharmaceutical equipment.
- Provide technical support, training to manufacturing, QA, validation and other departments for new process implementation, change control.
- Provide project management improvement initiatives to support the projects flawless implementation.
- Review and assist in the development of process flow diagrams (PFD), Piping and Instrument Drawings (P&ID), and process descriptions for projects and for the technology transfer of products.
Candidate should possess strong computer skills and work in a team environment, possess excellent written (documentation) and oral (presentation) communication skills.
The excellent knowledge of English is a mandatory requirement.
- 5+ years industry experience should include supporting process design for engineering projects which include aseptic processing and/or oral solid dosage manufacturing.
- BS in Engineering (Mechanical or Chemical preferred).
- Must be hands on and field experience.
- Project Management Skill
- Industry experience related to GMP drug manufacturing preferred.
- Industry experience in technology transfer and process optimization preferred.
- AutoCAD, SCADA skills are a plus.
- Knowledge of FDA and EMEA guidelines and manufacturing experience are a plus.
- ability to effectively build and maintain relationships in order to effectively negotiate and solve problems
- ability to organize, prioritize and deliver tasks & projects with a sense of urgency
- oral and written communication skills
- attention to detail
- ability to exhibit flexible thinking
- continuous improvement and quality mindset
- ability to enable and drive change
Place of work: Latina
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Umana SpA – div. ALTI PROFILI
Ancona - Bologna – Milano – Perugia – Pordenone – Roma - Venezia