Manufacturing Process Expert M/W

Job Summary:

The Manufacturing Process Expert will be responsible for technical and scientific support to manufacturing (MFG) shopfloor and will manage timely completion of MFG activities (compliance, TT, campaign preparation, troubleshooting…).

Coaching of MAs regarding main area of expertise and side processes is a focus area.

The Process Expert II will be responsible for overseeing and managing intra, cross-site, and cross-functional projects related to process and productivity improvements. The main responsibility is within management of recipe driven operations, process equipment, deviation

management, changeover, tech transfer, projects (change control and CI) and direct process support as applicable.

Principal Accountabilities:

• Acts as Subject Matter Expert on manufacturing equipment and processes
• Partner with direct manager to assign appropriate resources to tech transfers,
• drive continuous improvement, ensure manufacturing instructions are clear, safe, and compliant
• Initiates, owns, and manages Manufacturing focused Change Controls, CAPAs, and
• Planned Exceptions. Supports in generating area assessments and performs root cause investigations in DEV/AA/RAR reports in Trackwise.
• Utilizes depth of experience and known precedent to identify, troubleshoot, and resolve moderately complex technical and operational problems that arise.
• Creates projects as needed to establish new manufacturing techniques to resolve
• day to day issues with management guidance and cross-functional buy-in.
• Proactively identifies continuous improvement opportunities, shares knowledge

cross functionally, and drives site and/or global implementation

Minimum Education Requirements:

High school diploma or equivalent as a minimum. Bachelor’s degree or higher preferred

Minimum Experience Requirements:

• 8-years of direct experience working in a GMP environmen
• Very detail oriented with very excellent documentation skills.
• Coaching and Trainer skills for Manufacturing related activities
• Deputy function for MTO Manager role
• High knowledge of business and manufacturing processes to support manufacturing operations.
• High knowledge of Manufacturing Systems (DeltaV, Syncade, SIMCA, PI, Oracle, TrackWise, etc.)
• Very good understanding of the basic QA and cGMP principles
• Good understanding of Delta V or Syncade or similar automated systems.
• Understanding of full Biotech process.
• Languages: English B1, German and/or French are assets.

Got what it takes? Apply now and join us in making a difference in the pharmaceutical industry!