Manufacturing Engineer / Ingenieur - MBR Design

Summary: The Manufacturing Engineer - MBR Design role involves overseeing and communicating updates to Master Batch Records (MBRs) in a pharmaceutical manufacturing environment. The position requires participation in design workshops, validation activities, and providing support during the MBR verification process. The role is based in Neuchâtel, Switzerland, with a focus on collaboration and compliance within manufacturing processes.

Key Responsibilities:

• Oversee and communicate MBR updates and request changes per manufacturing requirements.
• Attend MBR design workshops to provide input and follow completion for sustaining support.
• Participate in dry runs and execute MBR verification activities.
• Execute test orders and provide feedback to MBR designers.
• Support MBR Verification by creating test steps and executing protocols.
• Provide primary HyperCare for site Go-Live and assist in end user training.
• Support validation MES system activities including IQ/OQ/PQ and write execution protocols.
• Ensure MBR reflects the manufacturing process and gather necessary data points.
• Create Master Data and manage object management setup.
• Follow Global MBR Design Rules.

Key Skills:

• Minimum 5 years of experience in MBR/Master Batch Record Design (PAS-X 3.2) in a Life Sciences/Pharma company.
• University degree in engineering, manufacturing, supply chain, or development is advantageous.
• Profound experience in MES system activities (IQ/OQ/PQ) and protocol writing/execution.
• Experience in MBR verification and validation activities.
• Experience in Master Data creation and object management setup.
• Strong team player with ownership and accountability.
• Business fluent in both French and English, verbal and written.

Salary (Rate): undetermined

City: Neuchâtel

Country: Switzerland

Working Arrangements: on-site

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other