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 overseeing external contract organizations, and/or managing internal staff.
•    Experience with spray drying.
•    Microbiology experience is a plus.

Reports to:

• Direct to Sr. Manufacturing Engineering Manager – Engineering.
• Dotted line to Process Development Senor Scientist – Research & Development.

Ferring + you   

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.  

Our Compensation and Benefits 

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $91,500 to $130,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location.  Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.

Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws. 

Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.  

We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.  

Location: