Senior Process Engineer- bio
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Reporting to the Process Engineering Manager, the Process Engineers / will be responsible for delivery of robust drug substance process manufacturing systems by guiding detail design, equipment selection, supporting startup & qualification activities, and the resolution of technical issues.
The Process Engineers will have ownership over a specific set of equipment systems as the project progresses through design, construction, and start-up:
- Responsible for process design to ensure delivery of assets and capacity as defined by project goals, to meet business objectives.
- Oversees detail design for system, including close management of design and fabrication of vendor systems.
- Assures all design & project work is completed in compliance with all Regulatory requirements including, Quality (cGMP, Quality Directives), EHS, Global Engineering, design & construction directives, requirements and procedures.
- Responsible for process system cost to ensure it remains within the budget & cash flow projection forecast.
- Contributes to definition of commissioning and qualification approach.
- Responsible for regular communication across functional lines (e.g. Construction Manager, Automation, Quality, Utilities, etc.) to ensure design and startup activity coordination as well as resolution of technical issues.
- Assists in the management of outside contractors, assures construction & contractor safety and environmental compliance with all company policies & government regulations.
- The successful candidate must possess a Bachelor of Science in engineering, biologics or chemistry or related discipline.
- Experience in the design and construction of biopharmaceutical manufacturing facilities Experience in engineering support of cGMP biopharmaceutical manufacturing processes and facilities preferred.
- In addition problem solving, and project management and a demonstrated ability to meet deadlines is essential. Proven success working well in a team environment with flexibility to react to changing business needs is required.
The candidate must have the rights to work in the location stated in the job advert.
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