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Process Validation Engineer

Title : Process Validation Engineer profile
Sector : Engineering & Technical
Location : Cork
Reference : CW120243
Contact : Mike Morrissey
Office : Cork
Tel : 00353-21-4297536
Email : mmorrissey@careerwise.ie

Job Description

Process Validation Engineer (12 Month Contract) is required by CareerWise Recruitment for our Cork based Client. Process Validation Engineer, plays a key role in the planning and execution of validation activities related to new product introductions, product transfers, new technologies and process changes. Provides support for the validation activities associated with equipment & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed.

Role of this position

  • Assist in development of validation strategy and validation plan for equipment and process validations.
  • Assist in the development of sampling plans, test plans and data analysis related to process validation.
  • Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
  • Review and approve documents prepared by project teams, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls)
  • Assist in resolution of deviations/ exceptions during qualification activities Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions
  • Mentoring of Quality/Engineering colleagues with respect to validation activities.

JOB REQUIREMENTS

  • Hons. Degree Quality/ Manufacturing / Engineering / Science
  • Minimum of 3-5yrs experience in Quality Assurance/Engineering (a minimum of 2 years of which has been spent carrying out validations)
  • Working knowledge of Quality systems (FDA/ISO) within a regulated environment
  • Process validation experience
  • Ability to analyse Capability data using MINITAB

Please call Mike Morrissey today for further information on 021-429 7536 or email: mmorrissey@careerwise.ie CareerWise Recruitment (

IN SEARCH OF EXCELLENCE
) CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999 CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.


 

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Careerwise Recruitment



Process Validation Engineer

Title : Process Validation Engineer profile
Sector : Engineering & Technical
Location : Cork
Reference : CW120243
Contact : Mike Morrissey
Office : Cork
Tel : 00353-21-4297536
Email : mmorrissey@careerwise.ie

Job Description

Process Validation Engineer (12 Month Contract) is required by CareerWise Recruitment for our Cork based Client. Process Validation Engineer, plays a key role in the planning and execution of validation activities related to new product introductions, product transfers, new technologies and process changes. Provides support for the validation activities associated with equipment & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed.

Role of this position

  • Assist in development of validation strategy and validation plan for equipment and process validations.
  • Assist in the development of sampling plans, test plans and data analysis related to process validation.
  • Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
  • Review and approve documents prepared by project teams, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls)
  • Assist in resolution of deviations/ exceptions during qualification activities Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions
  • Mentoring of Quality/Engineering colleagues with respect to validation activities.

JOB REQUIREMENTS

  • Hons. Degree Quality/ Manufacturing / Engineering / Science
  • Minimum of 3-5yrs experience in Quality Assurance/Engineering (a minimum of 2 years of which has been spent carrying out validations)
  • Working knowledge of Quality systems (FDA/ISO) within a regulated environment
  • Process validation experience
  • Ability to analyse Capability data using MINITAB

Please call Mike Morrissey today for further information on 021-429 7536 or email: mmorrissey@careerwise.ie CareerWise Recruitment (

IN SEARCH OF EXCELLENCE
) CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999 CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.


 

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  • mincon
  • 21-lg-kostal
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  • Carberry Group
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  • AMCS
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  • Johnson Controls
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  • Gilead

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