Manufacturing Specialist

Who We Are

Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.

About the Job

The Manufacturing Specialist will work with the operation leadership and product development teams to propose and implement manufacturing processes for new products. They will also assist in the development of changes for existing products to reduce the opportunity for defects in drug manufacturing. Process improvements for LEAN manufacturing and Operational Excellence are also in scope for this role to provide additional value to the business and increase production while maintaining or reducing overhead cost. Currently this includes the transition of products from raw material compounding to sterile packaging from registered FDA drug manufacturers. The specialists’ role is also implementing electronic batch records for the operations team as they transition away from paper based systems.

Key Responsibilities

• Assist in the execution of new product development protocols as necessary including engineering runs, media fill, and stability studies
• Create new batch records and support documentation
• Draft and revise Standard Operating Procedures (SOPs)
• Author change controls for process updates
• Updating existing batch records for process improvements
• Train with the Deviation Management System (DMS) to write investigations
• Assist with commercial compounding and filling operations as necessary

Basic Qualifications

• Bachelor’s degree in area(s) of study necessary for the role: Industrial, Mechanical, or Manufacturing Engineering; Engineering Management; or closely related
• Minimum 1 year of manufacturing experience
• Expertise in Technical Writing: Controlled Documents, Training Materials, Investigations, CAPAs or Similar
• Proficient in Good Documentation Processes
• Drug Manufacturing Experience Is Preferred

What's on Offer?

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Ready for the challenge?
Job Reference: NA00347