Process Engineer / no-097

Status: 
closed
Location: 
Stein
Start Date: 
2019-02-01
End Date: 
2019-07-31
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
1.032
Assignment: 

Background

For our customer located in Stein/Switzerland we are currently looking for (m/f) a Process Engineer

  • Type of placement: 6 months
  • Company:  major Pharma company in Stein area
  • Salary: level 2, please ask us for the exact rate range 

(monthly all in salary levels in CHF,  level1= 5-10k , level2=10-15k,  level3= >15k)
 

Provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines and normatives 
 

Shop floor support

  • 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 

Validation - execution and review of protocol/report

  • 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 

 

Technical improvement execution

  • Execute process improvements, scale-up 
  • Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables

Primary packaging closure assessment during changes

  • 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 

Assure consistency of Master Batch Records

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

Deviation, Out Of Expectation, Out Of Specification, complaint handling

  • Lead product and process related investigations and deviations including complaints, 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

Annual Product Reviews and Product Quality Reviews

  • 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 

Training

  • Provide training for assigned new processes and products 
  • Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining this position 

Audit support

Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit 

Requirements: 

 

Education (minimum/desirable)

  • BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. 
  • Desirable MSc. or equivalent experience. 
  • Languages: Fluent in English and proficient in site local language. 

Relevant Experiences

  • Minimum 3 years experience in process support role on the shopfloor of GMP manufacturing and/or QA/QC. 
  • Proven process understanding (Pharma, GMP, Regulatory aspects). 

 

Kindly be informed that this job offer  is from our customer in Switzerland. Therefore we can only accept applications within the EU or applicants with Swiss work permissions.  
Please attach your CV in Word format. 
SimplyVision is looking forward to your application.