Senior Engineer MSAT LM DP STO

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Come and join us to create a future where disease is a thing of the past. At our Schaffhausen Site we launch new products with focus on Parenteral Products (e.g., Prefilled Syringes and vials).

We belong to the Manufacturing, Science & Technology (MSAT) organization for the MTO (Manufacturing and Technical Operations) Large and Small Molecule Manufacturing Platform. We support Small Molecule API and Drug Product operations and the Parenteral small and large molecule Filling, visual inspection, device assembly and pack operations at JSC Schaffhausen, Janssen Supply Chain and currently we are looking for a MSAT Validation Staff Engineer to be based in Schaffhausen, Switzerland to join our team.

POSITION SUMMARY:

You will be the Site MSAT representative on cross functional teams owning the responsibility for the reliability of product processes of commercial product and new product introductions for non-biologic and biologic parenteral liquids, suspensions, and lyophilized products at the Schaffhausen Fill Finish site. You will provide the following:

• Technical support and leadership to top line growth

• Enhance reliability, compliance & efficiency of product value chains end to end

• Integrate Manufacturing Operations and Pharmaceutical Development in partnership with Product and Customer Management

RESPONSIBILITIES:

• Site Technical Owner for New Product Introductions, Tech Transfer Projects and specific commercial product

• Own and coordinate validation activities with internal partners

• Lead cross functional project teams

• Implement Process Capability/Quality/Cost Improvement Changes

• Provide Technical Assessments to Change Controls/CAPAs and Deviations

• Active participation in inspections as Subject Matter Expert

• Maintain excellent partnership with all business partners

• Execute statistical analyses on production data

Qualifications

• Yu have a Degree in Chemistry or Pharmacy or equivalent

• You have 4+ years of experience in the pharmaceutical sector overall with past proven field experience in the following areas:

• Parenteral drug product manufacturing

• Quality Assurance and Regulatory Compliance cGMP

• Leading GMP Investigations

• Experience in the following fields are of advantage, but not a must:

• DP manufacturing process validation

• Leading cross-functional teams and project

• Leading GMP investigations

• You have strong decision making and problem-solving competencies

• You are a flexible, motivated, and innovative team player

• You are open to new ideas and driving innovation

• You are proficient in English and you have basic German knowledge

We are offering

a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure at the Janssen site Schaffhausen.

• Many opportunities to work on exciting projects and assignments.
• Childcare benefit
• A broad spectrum of training opportunities to grow further for personal as well as professional development
• The Johnson & Johnson Pension Fund Switzerland offers attractive performance
• A range of benefits for insurance, products, sport, culture and much more