76 days ago on sjobs.brassring.com

Senior Process Expert

Novartis Pharma Schweiz AG

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Senior Process Expert

Job ID 222047BR Position Title Senior Process Expert Division Novartis Technical Operations Business Unit NTO SOLIDS Country Switzerland Work Location Stein (Säckingen) Company/Legal Entity Novartis Pharma AG Functional Area Technical Operations Job Type Full Time Employment Type Regular Job Description •Provide front line support to manufacturing (operators), working with Coordinators, Plant Engineers, QA operations.

•Support the execution of process validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shopfloor to ensure accurate execution

•Review and assure that validation protocols and report are technically correct

•Ensure protocols are executed as intended

•Acts as Launch Lead for the Process Unit

•Execute process improvements

•Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables

•Ensure that all critical and significant parameters are within written Instruction (i.e. Master Batch Record, Validation Plan), sufficient and appropriate for the product

•Lead product and process related investigations and critical deviations, Out Of Expectation, Out Of Specification

•Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures

•Be highly knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis and for driving process technology innovations

•Be a resource to other departments as Subject Matter Expert for the product and process knowledge

•Provide training for assigned new processes and products

•Acts as mentor for Process Experts

•Acts as Subject Matter Expert for Audits

•Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit
Minimum requirements •BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.

•Desirable MSc. or equivalent experience.

•Fluent in English and site local language.

•Minimum 5-7 years experience in process support role on the shopfloor of GMP manufacturing and/or QA/QC.

•Proven process understanding (Pharma, GMP, Regulatory aspects).