Manufacturing Support Specialist

in the position as Manufacturing Support Specialist  you support the operation team as well as the project team for operational and GMP readiness of the new production facility for recombinant products during the project phase

Later in the commercial phase, the main task is to ensure the operational support and compliance of routine production

Your Responsibilities:

• Support the activities related to material readiness, including definition, selection and introduction of raw materials.
• Support stock management (Kanban) and logistic aspects of all materials used in operations
• support the setup of routine tier structure, shift organization, governance and deputation,
• member of on-call service
• support the update of documents, authoring of curricula and set up consecutive training execution (on the job, class room)
• convene and lead meetings with partners to elaborate on assigned topics based on project schedule and project needs related to operational readiness
• support automation readiness including assessment of requirements, planning of training and supporting software parameter updates
• riving the manufacturing compliance readiness as CAPA/deviation management and trending with important metric

Commercial Operations Phase:

• responsible for the daily manufacturing operations support
• deputy of lead operation support in order to run areas robustly and GMP compliant
• update of documents, curricula and consecutive training for qualification of manufacturing employees
• build cross functional teams and get along with other support functions such as Quality Assurance, Quality Control, Manufacturing, Engineering, Validation, and other relevant functional areas

Your Qualifications:

• Requires Bachelor/master’s in chemistry / Biochemistry / Biology / Food Science
•  You speak English and German fluently
• several years successful experience in pharmaceuticals operations in a GMP relevant environment;
• user skills in common software used in pharmaceutical industry
• used to work independently in a multifaceted and fast paced environment as well as optimally in cross-divisional teams
• willingness to do service for an on-call organization for shift mode and to weekend work according to need resp. of production planning