Process Engineer - must have Pharmaceutical/Medical solutions experience.

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Job ID:

1087275

Location:

Lancashire 

Category:

Engineering

Salary:

£35,000.00 per year
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Job Views:

2468

Employment Type:

Full time

Posted:

19.05.2016
col-wide   

Job Description:

We are working with pharmaceutical solutions engineering company based in Lancashire. They are looking for an experienced Process Engineer to join their team.
 
The purpose of the role is to develop and define manufacturing methods and processes for a range of  pharmaceutical/medical solutions. Responsible for the design and execution of validations to support  the smooth transition of products and processes from development to full scale production.
 
KEY RESPONSIBILITIES:
  • Supports manufacturing by identifying opportunities and implementing improvements which increase efficiencies, improve quality of infrastructure and reduce waste.
  • Develops work instructions, work flows, work stations and factory layouts.
  • Utilises tools to support repeatable process transfer from development to full scale production.
  • Execution of risk management assessments (pFMEAs)
  • Responsible for specification, procurement, installation management and commissioning of process and infrastructure equipment.
  • Definition and documentation of production processes including the capturing of routings on the ERP system.
  • Design of Master Validation Plans (VMP), Validation protocols, execution of Validations and the generation of Validation reports (for both internal and external processes)
  • Collate and analyse data and generate technical reports
  • Management of all equipment calibrations and management of calibration registers
  • Management of asset registers
  • Definition of critical spares lists for production and infrastructure equipment.
  • Conducts deviation investigations and troubleshoots and resolves issues as needed.
  • Support of change control process related to BOM's, Work Instructions, Drawings, Specifications and Travellers.
 
 
 
ADDITIONAL RESPONSIBILITIES:
  • Provide project support to the Engineering/Development teams
  • Provide specialist project support to Operations (where required) on site expansion, significant changes to processes or business structure
  • Second line support to production on process support and improvement.
 
QUALIFICATIONS AND EXPERIENCE:
Essential:
  • Minimum 3 years’ experience within industry-sector
  • Bachelor's degree or equivalent in a relevant technical discipline.
  • Knowledge of Standards Applicable to Medical Device Safety Risk Management (ISO 13485, ISO 14971 and related standards)
  • Experienced in the practical application of Engineering principles
  • Experience and expertise in either plastic moulding or PVC extrusion.
  • Knowledge of Design Control Systems and ability to apply project management techniques
  • Experience managing a risk management process (pFMEA/dFMEA) or similar.
  • Experience of Product transition from development to full scale production
  • Demonstrated knowledge of Good Manufacturing Practice (GMP)
  • Effective oral and written communication
Preferred:
  • 5+ years’ experience within industry-sector
  • Certified practitioner in Six Sigma (DFSS or DMAIC) or Kaizen techniques.
  • Use of statistical packages for analysis (e.g. MINITAB or similar)
  • Knowledge of validation and the use of Design of experiment
  • Experience managing a comprehensive risk management process for complex pharmaceutical/medical devices (pFMEA/dFMEA) or similar.
  • Experience with supplier management and component qualification practices
  • Experience managing a project team of highly technical individual contributors.
 
Agency:UCA Consulting
Contact Name:Richard Lalchan
Contact Email:richard@ucaconsulting.uk
Telephone:0208 429 5297
Industry:Engineering
Job Type:Permanent
Location:Lancashire
Salary:Up to £35k depending on experience
Company Info
UCA Consulting Talbot House Business Centre, 204-226 Imperial Drive Harrow Greater London
London, Middlesex, United Kingdom

Phone: 020 8429 5138
Web Site: http://www.ucaconsulting.co.uk

Company Profile




Company Info


UCA Consulting
Talbot House Business Centre, 204-226 Imperial Drive Harrow Greater London
London, Middlesex, United Kingdom
Phone: 020 8429 5138
Web Site: http://www.ucaconsulting.co.uk

Process Engineer - must have Pharmaceutical/Medical solutions experience.

col-narrow-left   

Job ID:

1087275

Location:

Lancashire 

Category:

Engineering

Salary:

£35,000.00 per year
col-narrow-right   

Job Views:

2468

Employment Type:

Full time

Posted:

19.05.2016
col-wide   

Job Description:

We are working with pharmaceutical solutions engineering company based in Lancashire. They are looking for an experienced Process Engineer to join their team.
 
The purpose of the role is to develop and define manufacturing methods and processes for a range of  pharmaceutical/medical solutions. Responsible for the design and execution of validations to support  the smooth transition of products and processes from development to full scale production.
 
KEY RESPONSIBILITIES:
  • Supports manufacturing by identifying opportunities and implementing improvements which increase efficiencies, improve quality of infrastructure and reduce waste.
  • Develops work instructions, work flows, work stations and factory layouts.
  • Utilises tools to support repeatable process transfer from development to full scale production.
  • Execution of risk management assessments (pFMEAs)
  • Responsible for specification, procurement, installation management and commissioning of process and infrastructure equipment.
  • Definition and documentation of production processes including the capturing of routings on the ERP system.
  • Design of Master Validation Plans (VMP), Validation protocols, execution of Validations and the generation of Validation reports (for both internal and external processes)
  • Collate and analyse data and generate technical reports
  • Management of all equipment calibrations and management of calibration registers
  • Management of asset registers
  • Definition of critical spares lists for production and infrastructure equipment.
  • Conducts deviation investigations and troubleshoots and resolves issues as needed.
  • Support of change control process related to BOM's, Work Instructions, Drawings, Specifications and Travellers.
 
 
 
ADDITIONAL RESPONSIBILITIES:
  • Provide project support to the Engineering/Development teams
  • Provide specialist project support to Operations (where required) on site expansion, significant changes to processes or business structure
  • Second line support to production on process support and improvement.
 
QUALIFICATIONS AND EXPERIENCE:
Essential:
  • Minimum 3 years’ experience within industry-sector
  • Bachelor's degree or equivalent in a relevant technical discipline.
  • Knowledge of Standards Applicable to Medical Device Safety Risk Management (ISO 13485, ISO 14971 and related standards)
  • Experienced in the practical application of Engineering principles
  • Experience and expertise in either plastic moulding or PVC extrusion.
  • Knowledge of Design Control Systems and ability to apply project management techniques
  • Experience managing a risk management process (pFMEA/dFMEA) or similar.
  • Experience of Product transition from development to full scale production
  • Demonstrated knowledge of Good Manufacturing Practice (GMP)
  • Effective oral and written communication
Preferred:
  • 5+ years’ experience within industry-sector
  • Certified practitioner in Six Sigma (DFSS or DMAIC) or Kaizen techniques.
  • Use of statistical packages for analysis (e.g. MINITAB or similar)
  • Knowledge of validation and the use of Design of experiment
  • Experience managing a comprehensive risk management process for complex pharmaceutical/medical devices (pFMEA/dFMEA) or similar.
  • Experience with supplier management and component qualification practices
  • Experience managing a project team of highly technical individual contributors.
 
Agency:UCA Consulting
Contact Name:Richard Lalchan
Contact Email:richard@ucaconsulting.uk
Telephone:0208 429 5297
Industry:Engineering
Job Type:Permanent
Location:Lancashire
Salary:Up to £35k depending on experience