CSV Consultant

CSV Consultant   Reference: TPS032  
SALARY Negotiable   LOCATION Netherlands
JOB TYPE Contract (12 months)   DATE POSTED 16/01/2018
INDUSTRY Pharmaceutical      
         
DESCRIPTION        
Validation Engineer IT

Purpose of the function:

The Validation Engineer IT is responsible for managing IT validations from start to finish (also often referred to as computerised system validation). For …………………. this concerns the validation of IT systems that are typical for pharmaceutical production companies, including ………………………………………. The so-called Process Control systems, such as SCADA systems that are used to control and monitor production lines, also belong to this category.

Main tasks and responsibilities:

Performing GMP impact assessments.
Ensure that the quality requirements from the regulations and …………… standards are translated correctly to the user requirements of a system. Consider requirements regarding Back-up & Restore, Incident Management, Disaster Recovery, Electronic Records and Electronic Signatures.
Determine and implement a validation approach for the system (including any interfaces).
Facilitating so-called Design Verification (or Design Qualification) sessions;
Managing the tests according to a structured and formally established procedure.
Assess and report the test results. Review deviations and corrective measures and coordinate possible re-tests.
Ensure that suppliers comply with Astellas standards for design, documentation and validation.

Professional profile:

Educational attainment
Minimum HBO level (or thinking level)
Knowledge of the formulation and packaging processes.
Preferably knowledge of Electronic Batch Records Systems, Laboratory Information Systems or systems that are comparable in terms of complexity and degree of integration.
Knowledge of GMP regulations (Eudralex Volume 4, 21 CFR Parts 210, 211 and 11) and ISPE Good Practice Guides (GAMP5).
Knowledge of ICT and Industrial Automation.
Knowledge of System Life Cycle methodologies.
Competences Planning and organizing.
Analytical skills.
Quality-oriented and accurate work.
Excellent communication skills in word and writing both in English and in Dutch.
Experience
Minimum 5 years experience in the pharmaceutical or medical device industry or laboratory.
Minimum 3 years experience with the validation of computer systems in the aforementioned industries.
Experience with the validation of an Electronic Batch Records Systems, Laboratory Information Systems or systems that are comparable in terms of complexity and degree of integration.
Experience with System Life Cycle methodologies.

Recruiting Consultant – Charlie Burgess – 0208 432 6080

 

 

 

       
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Delta V Engineer

Delta V Engineer    Reference: TPS027  
SALARY £50,000 +   LOCATION United Kingdom
JOB TYPE Permanent   DATE POSTED 05/12/2017
INDUSTRY Process (Food & Pharma)      
Requirements  5 years AI

2 years Delta V

     
DESCRIPTION        
 

As a lead Automation Engineer you will be Reporting to the Lead Automation Commissioning Engineer, responsible for supporting CQV teams with Loop checking, troubleshooting devices on DeltaV, Fault finding, Commissioning and troubleshooting on the DeltaV software. PID Loop tuning is an important factor in the senior commissioning engineer’s role.

Requirements

  • 5 years’ Automation experience
  • DeltaV Experience 2 years
  • Knowledge of S88
  • Software design experience Base layer to Phase
  • English is of good work proficiency
  • Knowledge of GMP
  • Change management Experience
  • AMS experience
  • Loop checking
  • Minimum 3 years Commissioning experience in a plant

Desired experience:

  • Instrumentation electrical etc experience
  • Mynah VIM experience
  • Loop tuning PID tuning
  • Communication protocols Foundation fieldbus, Devicenet, Profibus and Modbus
  • Life science experience Minimum 2 years
  • HyperV

 

 

       

Senior Control Engineer (Ireland)

Senior Control Engineer    Reference: TPS018  
SALARY Negotiable LOCATION Ireland
JOB TYPE Permanent DATE POSTED 17/08/2017
INDUSTRY Pharmaceutical
  PLC focused  Allen Bradley
DESCRIPTION HMI SCADA Wonderware
Established automation System Integrator in Ireland requires experienced Controls Engineers to engage on two separate projects in Ireland (Cork or Limerick). The position is focused in the healthcare/nutrition space and will require you will have a minimum of 5 years’ experience working with validated Automation systems in the pharmaceutical manufacturing environment.

The suitable candidate for this position will be responsible for;

  • Development and implementation of software solutions through change control as required while understanding impact of actions to Manufacturing and Facilities equipment.
  • Ability to program, diagnose and troubleshoot Allen Bradley Rockwell PLC and HMI application for automated process equipment.
  • Provide technical and automation operational support to Engineering, Manufacturing, Validation and Facilities departments.

My client requests that your profile shows a good level of long-term commitment on Permanent opportunities in previous careers. They offer high level of investment in their candidates i.e training courses, skill development.

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