Sr. Specialist, Engineering; m​/f​/d

Job Description Our Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open position to support sterile drug product manufacture within our External Manufacturing Network in Europe. This is an exciting opportunity to work with key strategic external partners, grow technical experience in sterile manufacturing, and work on high visibility network initiatives with direct access to senior management.

Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the large molecule lines of business at our company. Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

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.
• 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.
• Driving change both internal and external ensuring state of the art technology and processes are implemented and maintained.
• 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.
• Lead and 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.
• Support / Lead critical technical projects relating to the manufacturing of commercial sterile drug product.
• 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.

• 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.
• Experience in Relationship Management

• 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.
• Flexibility and the ability to work independently as well as excellent organizational skills.
• Strong knowledge of Quality systems, Change Control Drug Product Manufacturing and Validation
• Strong analytical problem-solving…