Manufacturing Process Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Sturgis, MI location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands including Similac, PediaSure, Pedialyte, Ensure, and Glucerna to help them get the nutrients they need to live their healthiest lives.

For over 70 years, Abbotts Sturgis, Mich. , has been impacting its community while producing products that provide essential nutrition to millions of families around the world. Working here, youll feel part of a family that is dedicated to making a difference and helping others.

Responsibilities:

• Support commercial drug product manufacturing operations with technical evaluation of NCMR/CAPA, scale up, validation, and technology transfer. This includes drug product manufacturing (material preparation, mixing, molding, and inspection) and reserve samples (creation, storage, and testing).
• Support of regulatory filings and inspections.
• Troubleshoot issues with drug product processing technologies and equipment.
• Provide process development expertise for polymer-small molecule sterile drug product processing in specific areas such as formulation development, process characterization, sterile processing, tech transfer, validation and drug product manufacturing.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory agencies, company policies, operating procedures, processes, and task assignments.
• Transfer of new device assembly requirements to manufacturing with hands-on technical support: including developing Six Sigma processes/documentation for routine clinical and/or commercial production.
• Ensure that qualification parameters and process validation are complete for drug product-Medical Device assembly requirements.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Projects involve collaborating with cross-functional teams developing and executing tests, performing root cause analysis and participating in investigations. Also making presentations to internal/external customers, vendors, and senior management
• Conduct risk assessment for drug product operations non conformances, change controls, and implement appropriate CAPAs.
• Lead process modelling, data trending and advanced statistical & process analysis present data/metrics to teams.
• Implement process improvement strategies to improve quality, reliability and/or reduce cost.
• Minimal domestic and international travel as needed.

Education:

• Bachelor's Degree 3-5 years of Process Engineering or Operations experience OR a Master's Degree + 3 years of Process Engineering or Operations experience.
• Process/equipment development and optimization experience in small drug molecules and polymers based drug delivery systems. Knowledge of late stage or commercial products experience with strong focus on manufacturing support.
• Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, PFMECA, DFMECA.
• Strong knowledge of Quality systems, drug product manufacturing and process validation. Work history with cGMPs, regulatory filings and compliance issues for drug product and combination devices.
• Excellent organizational, leadership, teamwork, written and verbal communication skills together with demonstrated ability to work in a highly matrix team environment with enthusiasm and a proactive positive attitude.

The base pay for this position is

$60,000.00 $120,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Engineering DIVISION: ANSC Nutrition Supply Chain LOCATION: United States > Sturgis : Building 01A ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: EEO is the Law link - Espanol: