MSD Sr Specialist Engineering m/f/d 

Switzerland, Lucerne 

78382803

Job Description

Primary responsibilities for this position include, but are not limited to, the following:

• Manages technical issues relating to the global external manufacturing of commercial Drug Product.

• Takes accountability and ownership for Technical deliverables on their assigned projects.

• Provide technical leadership within Technical Operations group for the management of sterile drug product.

• Support technical transfers of new sterile drug product to our contract manufacturing sites.

• Lead to resolve technical issues relating to a product line or major technical projects within Technical Operation.

• Provide direct leadership for day-to-day technical activities for commercial drug product manufacturing –i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc.

• Independently act as the primary interface on technical issues between Technical Operations and third-party drug product manufacturers.

• Provide technical leadership on Change Controls, investigations, and CAPAs and support of Health Authority Inspections.

• Organize and lead ad hoc cross functional teams to manage investigations and implementation of CAPA and change controls.

• Coordinates and manages risk assessments and develops solutions to complex issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices and standards that govern the manufacturing of sterile products.

• This role includes approximately 25% travel.

Qualifications:

Education and Minimum Requirements:

• Bachelor’s degree in engineering, biological/chemistry sciences or related discipline

• A minimum of 7 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer.

• A minimum of 3 or more years of experience in sterile/ aseptic Drug Product processing including formulation and filling and technical transfers

• Experience in Relationship Management

Required Skills and Experience:

• Ability to work effectively across boundaries to build strong collaborative relation with other

• internal teams, such as; Global Technical Operations, Sterile, External Services partner groups, Small and Large Molecule Sites and external partners.

• Strong professional and interpersonal communication skills are also required.

• Must be able to multi-task and work within tight deadlines.

• Strong knowledge of Quality systems, Change Control Drug Product Manufacturing and Validation

• Strong analytical problem-solving skills, root cause analysis and riskassessment/mitigation

• Excellent command of English (both written and oral).

Preferred Experience and Skills:

• Project management experience

• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections

Current Contingent Workers apply

Not Indicated

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