Process Engineer

Reporting to the Process Engineer manager, the Process Engineers / Process System Owners 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. A minimum of 8 years of experience in the design and construction of biopharmaceutical manufacturing facilities and minimum 6 years experience in the support of the process system operations. Experience in engineering support of cGMP biopharmaceutical manufacturing processes and facilities preferred.

 


The candidate will have demonstrated proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills. 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.

 
If this role is of interest, please apply now.



The candidate must have the rights to work in the location stated in the job advert.

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