We are currently seeking a Senior Staff Manufacturing Engineer to join our Manufacturing Engineering team in Cary, IL. The Senior Staff Manufacturing Engineer will become part of a highly engaged, driven and successful team in support Sage’s unique portfolio of medical device, drug and cosmetic products produced at our world-class manufacturing facility. 

What you will do

As a Senior Staff Manufacturing Engineer, you will leverage your knowledge of automation and process engineering to drive meaningful business results.  You will provide technical support for our formulations mixing, equipment cleaning, and water purification systems.  You will understand business needs and requirements and translate them into equipment upgrades and improvements.  You will lead projects to improve safety, quality, and productivity of custom automated pharmaceutical mixing and converting processes.  Responsibilities include:

• Develop subject matter expertise in pharmaceutical formulations mixing equipment and processes, water purification systems and processes, and equipment cleaning systems and processes.
• Collaborate with product and quality engineering, equipment vendors, maintenance technicians and operations leadership to troubleshoot process and equipment issues.
• Lead design, development, and modification of equipment and processes including pharmaceutical manufacturing and distribution of aqueous solutions.  Identify new process technologies and seek opportunities to deploy.
• Deploy performance monitoring and lead practical problem solving (PPS) projects to remediate systemic issues.  Coach others in practical problem solving.
• Independently translate specifications and product designs into equipment requirements, PFMEAs and process control plans.
• Develop and execute equipment qualifications and complex process validations including and associated documentation.
• Develop and maintain appropriate supporting documentation, SOPs and work instructions compliant with Good Manufacturing Practices (GMP).
• Apply more advanced project management strategies and tools.
• Own complex NC/CAPAs related to areas of responsibility.
• Lead capital projects from end-to-end, including through vendor proposal stage, business case development, capital request development and approval, implementation and closeout.
• Coach and mentor more junior team members in areas of expertise.

Minimum qualifications:

• B.S. in chemical, mechanical, manufacturing engineering or related technical discipline
• 6+ years of manufacturing or industry experience
• 3-5 years of manufacturing engineering or automation experience.

Preferred qualifications:

• M.S. in chemical engineering.
• 8+ years of experience in manufacturing and automation, 6+ years of which were preferably in regulated manufacturing/industry environments. 
• Demonstrated experience in the field of formulations mixing (industrial process engineering).
• Custom automation experience.
• Evidence of continuous learning through progress towards an industry certification or advanced degree.
• FDA-regulated industry (pharmaceutical or medical device) experience.
• Demonstrated experience writing and executing validations (IQ, OQ, PV, etc.).
• Demonstrated experience owning and resolving quality non-conformances and CAPAs.