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SIP Validation Specialist

Title : SIP Validation Specialist profile
Sector : Engineering & Technical
Location : Limerick
Reference : CW121654
Contact : Conor Twomey
Office : Shannon
Tel : +353 21 4297422
Email : ctwomey@careerwise.ie

Job Description

SIP VALIDATION SPECIALIST required by CareerWise Recruitment for our multinational BioTech client in Limerick, initial 12 month contract on offer. The SIP VALIDATION SPECIALIST will be involved in the review and approval of SIP thermal mapping and Performance Qualification validation protocols, extensive experience on writing and approving Deviations required.

Role of this position

  • Experience in Validation specifically cleaning validation and thermal mapping.
  • Experience in assessment of cleaning issues during study runs,
  • Placement of thermocouple probes in vessel and transfer lines.
  • Experienced Technical writer,
  • Experience in Deviation/Change control writing,
  • Capable of managing a large program, so project management skills would be necessary,
  • An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment/ Theemal maapping works.
  • Troubleshooting of thermal mapping studies for investigation and Engineering studies.
  • Understanding of baseline studies for new equipment.
  • Experienced in coverage testing and clean-into-service.
  • Generate/review/Approval of CV/ SIP protocols,
  • Generate Reports.
  • Maintain and update Cleaning/ Steam in place Validation Plan.
  • Schedule of cleaning/SIP activities with Manufacturing.
  • Liaise with numerous departments.

JOB REQUIREMENTS

  • Ideally looking for 3-5 years Biotech cleaning/SIP validation experience
  • Experience in Document Preparation and Execution
  • Experience in major start-ups where clean-into-service, coverage testing, baseline studies in commissioning area, and cleaning and SIP validation studies may be concurrent activities in different trains.
  • Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing.
  • Have Troubleshooting and analytical mindset.

Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie

CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

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SIP Validation Specialist

Title : SIP Validation Specialist profile
Sector : Engineering & Technical
Location : Limerick
Reference : CW121654
Contact : Conor Twomey
Office : Shannon
Tel : +353 21 4297422
Email : ctwomey@careerwise.ie

Job Description

SIP VALIDATION SPECIALIST required by CareerWise Recruitment for our multinational BioTech client in Limerick, initial 12 month contract on offer. The SIP VALIDATION SPECIALIST will be involved in the review and approval of SIP thermal mapping and Performance Qualification validation protocols, extensive experience on writing and approving Deviations required.

Role of this position

  • Experience in Validation specifically cleaning validation and thermal mapping.
  • Experience in assessment of cleaning issues during study runs,
  • Placement of thermocouple probes in vessel and transfer lines.
  • Experienced Technical writer,
  • Experience in Deviation/Change control writing,
  • Capable of managing a large program, so project management skills would be necessary,
  • An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment/ Theemal maapping works.
  • Troubleshooting of thermal mapping studies for investigation and Engineering studies.
  • Understanding of baseline studies for new equipment.
  • Experienced in coverage testing and clean-into-service.
  • Generate/review/Approval of CV/ SIP protocols,
  • Generate Reports.
  • Maintain and update Cleaning/ Steam in place Validation Plan.
  • Schedule of cleaning/SIP activities with Manufacturing.
  • Liaise with numerous departments.

JOB REQUIREMENTS

  • Ideally looking for 3-5 years Biotech cleaning/SIP validation experience
  • Experience in Document Preparation and Execution
  • Experience in major start-ups where clean-into-service, coverage testing, baseline studies in commissioning area, and cleaning and SIP validation studies may be concurrent activities in different trains.
  • Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing.
  • Have Troubleshooting and analytical mindset.

Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie

CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

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