Sr 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 Sr Process Engineer will support cross-functional teams in the execution of complex projects related to pharmaceutical manufacturing equipment. Responsibilities include participating in equipment design, FAT/SAT, capital planning, and integration with site systems. The role ensures compliance with cGMP and site procedures, supports validation activities (IQ/OQ), and contributes to process improvements and investigations. It requires coordination with vendors, users, and fabricators, as well as occasional off-hours support. The individual acts as a subject matter expert for regulatory interactions, supports automation and control systems, and collaborates closely with Quality and Regulatory teams on documentation and change controls.

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:  

• Ensure full compliance with cGMP requirements and internal procedures, processes, and instructions for all assigned tasks.
• Support the design, fabrication, and commissioning of process equipment, including:
• Develop capital plans and execute planned and unplanned equipment initiatives.
• Coordinate activities with equipment users and external fabricators.
• Review and provide feedback on design documentation, SOPs, and validation protocols.
• Assist with integration of equipment into site networks, monitoring systems, and historians.
• Support validation team during Installation Qualification (IQ) and Operational Qualification (OQ) execution.
• Investigate equipment-related deviations and lead the implementation of corrective and preventive actions (CAPAs).
• Provide on-call support during off-hours, including nights, weekends, and holidays, to ensure continuity of production operations.
• Manage day-to-day engineering activities and prioritize tasks to meet project and production deadlines, including hands-on support on the production floor.
• Assist in programming, troubleshooting, and maintaining programmable logic controllers (PLCs) and building/process monitoring systems.
• Plan and coordinate on-site activities with vendors and contractors.
• Lead and facilitate FMEA and risk assessments on new or modified equipment.
• Assist with operations in cleanroom environments and represent the process equipment function in daily huddle meetings.
• Contribute to site-wide process improvement initiatives.
• Collaborate with other departments and manufacturing sites on special projects and quality-related issues.
• Serve as a subject matter expert (SME) on manufacturing systems and equipment during internal audits and regulatory inspections.
• Liaise with Quality Assurance and Regulatory Affairs teams to prepare or review documentation for regulatory submissions and change controls.

Requirements: 

• Bachelor’s degree in Engineering, preferably in Mechanical, Chemical, or Electrical Engineering.
• Minimum of 5 years of engineering experience in the pharmaceutical or biotechnology industry, with a strong emphasis on aseptic processing and lyophilization.
• Extensive knowledge of cGMP regulations and industry standards related to pharmaceutical manufacturing, equipment qualification, and validation.
• Proven ability to troubleshoot complex mechanical and process systems, including equipment used in sterile manufacturing environments.
• Demonstrated experience supporting the design, commissioning, qualification, and maintenance of pharmaceutical manufacturing equipment and systems.
• Strong analytical and problem-solving skills, with the abili