Senior Manufacturing Specialist.

On behalf of our client, we are seeking a Project / Process Engineer Senior Manufacturing Specialist I/II - MTO.

General Information:

• Contract type: temporary contract via Randstad.
• Start date: 03/03/2025
• End date: 27/02/2026 (with the possibility of extension)
• Location: Solothurn

Job Description:

The Process Expert II 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. The position requires strong manufacturing/technical process knowledge and/or strong knowledge of scientific principles as well as analytical skills to troubleshoot process issues and perform investigations. Responsibility is typically within the individual's business unit, but usually spans across business units. Leads or directs operational initiatives and projects with minimal supervision.

Principal Accountabilities:

• Acts as Subject Matter Expert on manufacturing equipment and processes. Participates in Tech transfer activities as needed. Authors related technical instructions and records, including RG/RT, procedures, work instructions, and forms.
• Partner with direct manager to assign appropriate resources to tech transfers, drive continuous improvement, ensure manufacturing instructions are clear, safe, and compliant. The incumbent can be both a people manager (Effectively lead and coach direct reports to meet career goals and business objectives. Addresses human resource development opportunities and challenges) as well as individual contributor with respect to technical instruction management for specific portions of a manufacturing process.
• Initiates, owns, and manages Manufacturing focused Change Controls, CAPAs, and Manufacturing, Manufacturing Sciences, Planned Exceptions. Supports in generating area assessments and performs root cause investigations in DEV/AA/RAR reports in Trackwise Process Engineering, BES, Automation, Quality, Planning, and Materials Management
• 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. Serves as CI Practitioner role when required by cross-functional teams.

Requirements:

• Education: High school diploma (minimum) or a Bachelor's degree (preferred) in a scientific field.
• Experience: At least 8 years in GMP-regulated environments.

Knowledge & Skills:

• High ability to interact with a cross-functional team effectively within organization.
• 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
• Very good level of technical writing skills
• Very good skills in Microsoft Office