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Process Engineer (NOVJP00024140) (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Engineering, Engineer
Projektbeschreibung
REFERENZNUMMER:
356201/11
IHRE AUFGABEN:
-Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements
-Support the execution of process validations, revalidations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution
-Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables
-Evaluate and assure, in case of packaging change, that the primary packaging closure - including materials - are sufficient to ensure stability of the product and do not deteriorate quality
-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 deviations including complaints, Out Of Expectation, Out Of Specification
IHRE QUALIFIKATIONEN:
-University degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
-Extensive experience in process support role on the shop floor of GMP manufacturing and/or QA/QC
-Proven process understanding (Pharma, GMP, Regulatory aspects)
-Fluent in English and proficient in site local language (German)
WEITERE QUALIFIKATIONEN:
Project manager
356201/11
IHRE AUFGABEN:
-Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements
-Support the execution of process validations, revalidations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution
-Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables
-Evaluate and assure, in case of packaging change, that the primary packaging closure - including materials - are sufficient to ensure stability of the product and do not deteriorate quality
-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 deviations including complaints, Out Of Expectation, Out Of Specification
IHRE QUALIFIKATIONEN:
-University degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
-Extensive experience in process support role on the shop floor of GMP manufacturing and/or QA/QC
-Proven process understanding (Pharma, GMP, Regulatory aspects)
-Fluent in English and proficient in site local language (German)
WEITERE QUALIFIKATIONEN:
Project manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges