Senior Process Engineer

Job Description:

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.

The Senior Process Engineer is an integral part of the product development (R&D) team, establishing expertise in the current state of the oral form manufacturing process design and leading technology transfer efforts.  Key goals will include a include expanding the capacity and improving yields of oral form manufacturing operations and transfer manufacturing process from Ferring R&D to manufacturing.

With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

Responsibilities: The responsibilities of the Senior Process Engineer include but are not limited to:

• Write and execute qualification/validation protocols for processes and equipment used in pharmaceutical development and manufacturing.
• Perform Process qualification and validation for oral dosage forms (encapsulation).
• Oversee the training and transition of the production process to manufacturing.
• Assist Regulatory with submission documents. (Report writing)
• Optimization of powder characteristics, blending and blending validation.
• Support the refinement of oral formulation to provide a more concentrated and/or more stable product.
• Building deep technical knowledge regarding the manufacturing of finished product, intermediates, and components.
• Lead the development and validation of long-term GMP-compliant manufacturing processes.
• Provide direct technical support to ongoing oral dose manufacturing operations.
• Contribute to strategic planning for commercial volume manufacturing.
• Assist in selection and qualification of key suppliers and/or contract manufacturing partners.
• Write manufacturing documentation such as process work instructions, and procedures.
• Specify, procure, install, and qualify equipment.
• Create and maintain specification documents for materials used in manufacturing.
• Write and execute qualification/validation protocols for processes and equipment.
• Develop and improve manufacturing processes and related documents.
• Facility related design work, specifications, controls, maintenance and improvement.
• Cleaning validation.
• Willing to be on call approximately 6 times a year for 1 week each.

Requirements:

Education and Experience:

• Bachelor’s degree in Engineering or related field required.
• Master’s degree in Engineering or related field preferred.
• Minimum 10 years of manufacturing/process development engineering experience required.
• Minimum 10 years in the pharmaceutical or biopharmaceutical industry.
• High attention to detail.
• Investigation and CAPA experience.
• Spray drying experience preferred.
• Experience in structured problem solving and use of statistical tools.
• Experience in design for manufacturing DFMEA, PFMEA, DOE and Validations. Automation experience a plus.
• Experience with data-based decision making preferred.
• Ability to apply sound engineering logic to solve complex problems to properly assess risks and make decisions accordingly.
• Can work independently and in a team setting.

• Experience with biological manufacturing and encapsulation.
• Experience writing and executing qualification/validation protocols for processes and equipment used in pharmaceutical development and manufacturing.
• Experience specifying, procuring, installing, and qualifying equipment in development laboratories and/or manufacturing processes.
• Experience writing manufacturing documentation including process work instructions and procedures.
• Infrequent on call work

Preferred

•    Experience in bioprocess engineering with demonstrated experience supporting the development of an IND enabling process.
•    Experience