Senior Process Engineer- bio
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.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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