Process Engineer - Operations/Quality Development Program (Secondment - 12 Months)

WHY PATIENTS NEED YOU

This role is a 12‑month secondment opportunity designed for high‑performing Operations and Quality professionals seeking to broaden their experience and gain meaningful exposure to the partner organization. The intent of this assignment is to deepen cross‑functional knowledge, strengthen collaboration between Operations and Quality, and develop future leaders with a strong end‑to‑end understanding of drug product manufacturing and compliance. This posting is for current Kalamazoo Drug Product Quality Assurance organization who are looking for experience and growth within the Drug Product Operation organization.

The successful candidate will be fully integrated into the drug product organization and will perform the day‑to‑day responsibilities of the role, serving as an active contributor to operational unit, compliance, and continuous improvement initiatives. This is a hands‑on assignment with accountability for delivering results while gaining practical experience working across multidisciplinary teams.

WHAT YOU WILL ACHIEVE

In this Operations role, the candidate will lead and support initiatives focused on cost savings, line efficiency improvements, and increased equipment capacity, while developing and validating manufacturing processes for drug products. They will contribute to troubleshooting and problem‑solving activities on the manufacturing floor, including supporting investigations, conducting root‑cause analyses, and implementing effective corrective actions in collaboration with Engineering, Maintenance, Quality, Validation, and Environmental Health & Safety.

This secondment provides a unique development opportunity to build technical depth, project leadership capability, and regulatory awareness while contributing tangible value to the business through operational improvements and sustained compliance.

This role will report to one of the Drug Product Senior Managers.

HOW YOU WILL ACHIEVE IT

• Identifies and implements cost savings ideas, specifically line efficiency improvements and other projects that increase equipment capacity.

• Develops and validates manufacturing processes for drug products, taking into consideration problems inherent in the transfer of technology from research to production, from other sites, or within the site.

• Conducts tests and measurements throughout stages of production to determine control over applicable variables.

• Support investigations that occur on the manufacturing floor. Performs root-cause analysis and identifies appropriate, effective corrective actions.

• Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety.

• Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.

• Serves as customer project manager on equipment purchases or improvements; interface closely with engineering to specify user requirements, review and approve drawings, define project scopes.

• Successful candidate must be familiar with tools and techniques required to manage large scale complex projects through multi-disciplinary teams.

• Collaborate with other enabling departments (Quality, Engineering, Maintenance, EHS etc.) to assure initiatives are successful.

• Lead and participate on teams to address compliance gaps identified through internal and/or external inspection activities.

• Provide guidance, coaching, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division.

• Identify and implement cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity.

• Incorporate Current Good Manufacturing Practices regulatory and safety compliance into all assigned projects' scope and design.

• Support and maintain an audit readiness program for all Drug Product areas and participate in regulatory/internal audits/inspections.

QUALIFICATIONS

Must-Have

• Applicant must have a bachelor's degree with at least 3+ years of experience; OR a master's degree with more than 1+ year of experience; OR an associate's degree with 6+ years of experience; OR a high school