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Senior Validation Engineer

Title : Senior Validation Engineer profile
Sector : Engineering & Technical
Location :
Reference : CW120399
Contact : Louise Mulligan
Office : Mayo
Tel : 094 900 3979
Email : lmulligan@careerwise.ie

Job Description

A Senior Validation Engineer is required by CareerWise Recruitment for our Westmeath based client. If you are interested in Validation with a Leading Pharmaceutical company ,then this is the job for you.

Role of this position

  • Leading and Managing projects for the validation equipment, processes and products to meet all safety, quality, regulatory and operational requirements.
  • Leading cross functional teams as part of project planning and deployment including collaboration with Quality, Safety, Operations, Facilities and Engineering, Supply Chain and Regulatory Affairs
  • Process mapping and gap analysis.
  • Review of equipment specification/design/procurement/installation and validation.
  • Project planning and execution including scheduling, task management, milestone planning and reporting.
  • Delivering projects on time and on budget.
  • Generation, review and approval of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
  • Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ ,OQ etc.),
  • To facilitate and participate in meetings and workshops as part of Continuous Improvement activities.
  • To approve plant SOPs and other documents as required, ensuring the acceptability of content and format.
  • Maintain the Site Validation Master Plan (VMP) and associated Project VMP’s, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency.
  • Accountable for compliance via documentation completion, risk assessments, review of protocols and reports, closing out preventative and corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Ownership accountability for execution of the sites Periodic Review and Re-qualification schedules.
  • Responsible for the implementation and execution of the process validation program and continuous process verification.
  • Manage and perform data analysis and lead/support investigations as required and support the team to make informed decisions/recommendations around conclusions reached from data analysis, using appropriate methodologies as required.
  • Responsible for authoring portions of regulatory submissions and defending the commissioning, design and qualification of GMP equipment to regulatory agency representatives during inspections.
  • Site audit facing validation SME

JOB REQUIREMENTS

  • 5- 8 years’ experience in a cGMP biopharmaceutical or aseptic filling environment.
  • Must have direct experience performing equipment, utility, and/or computer system qualifications studies in a cGMP aseptic filling environment.
  • Strong validation knowledge equipment of such as Autoclaves, Sterile Filler, Depyrogenation Tunnels, Vial Wash, VHP Isolator and HEPA systems.
  • Must have direct experience of performing validation studies of thermal sterilization processes including Autoclave validation, Steam in Place (SIP) validation, and validation of depyrogenation processes.
  • Experience of executing process validation of Drug Products and a good understanding of the tech transfer process.

Please call Louise Mulligan today for further information on 094 900 3979 or email: lmulligan@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 Mayo ,Cork, Shannon, Galway and Dublin

 

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Careerwise Recruitment



Senior Validation Engineer

Title : Senior Validation Engineer profile
Sector : Engineering & Technical
Location :
Reference : CW120399
Contact : Louise Mulligan
Office : Mayo
Tel : 094 900 3979
Email : lmulligan@careerwise.ie

Job Description

A Senior Validation Engineer is required by CareerWise Recruitment for our Westmeath based client. If you are interested in Validation with a Leading Pharmaceutical company ,then this is the job for you.

Role of this position

  • Leading and Managing projects for the validation equipment, processes and products to meet all safety, quality, regulatory and operational requirements.
  • Leading cross functional teams as part of project planning and deployment including collaboration with Quality, Safety, Operations, Facilities and Engineering, Supply Chain and Regulatory Affairs
  • Process mapping and gap analysis.
  • Review of equipment specification/design/procurement/installation and validation.
  • Project planning and execution including scheduling, task management, milestone planning and reporting.
  • Delivering projects on time and on budget.
  • Generation, review and approval of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
  • Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ ,OQ etc.),
  • To facilitate and participate in meetings and workshops as part of Continuous Improvement activities.
  • To approve plant SOPs and other documents as required, ensuring the acceptability of content and format.
  • Maintain the Site Validation Master Plan (VMP) and associated Project VMP’s, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency.
  • Accountable for compliance via documentation completion, risk assessments, review of protocols and reports, closing out preventative and corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Ownership accountability for execution of the sites Periodic Review and Re-qualification schedules.
  • Responsible for the implementation and execution of the process validation program and continuous process verification.
  • Manage and perform data analysis and lead/support investigations as required and support the team to make informed decisions/recommendations around conclusions reached from data analysis, using appropriate methodologies as required.
  • Responsible for authoring portions of regulatory submissions and defending the commissioning, design and qualification of GMP equipment to regulatory agency representatives during inspections.
  • Site audit facing validation SME

JOB REQUIREMENTS

  • 5- 8 years’ experience in a cGMP biopharmaceutical or aseptic filling environment.
  • Must have direct experience performing equipment, utility, and/or computer system qualifications studies in a cGMP aseptic filling environment.
  • Strong validation knowledge equipment of such as Autoclaves, Sterile Filler, Depyrogenation Tunnels, Vial Wash, VHP Isolator and HEPA systems.
  • Must have direct experience of performing validation studies of thermal sterilization processes including Autoclave validation, Steam in Place (SIP) validation, and validation of depyrogenation processes.
  • Experience of executing process validation of Drug Products and a good understanding of the tech transfer process.

Please call Louise Mulligan today for further information on 094 900 3979 or email: lmulligan@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 Mayo ,Cork, Shannon, Galway and Dublin

 

Companies we work with

  • 04-lg-roche
  • 05-lg-stryker
  • 06-lg-tyco
  • 09-lg-dairygold
  • 07-lg-depuy
  • 10-lg-bausch-lomb
  • cookmedicallogo
  • 12-lg-eli-lilly
  • 14-lg-medtronic
  • 15-lg-msd
  • 17-lg-minelab
  • Becton Dikinson
  • 18-lg-lake-region
  • mincon
  • 21-lg-kostal
  • 22-lg-dulux
  • ATSR Logo
  • 24-lg-bandon-co-op
  • Carberry Group
  • BBraun
  • Sanmina
  • AMCS
  • Flex
  • GE Sensing
  • Johnson Controls
  • VisionCare
  • Gilead

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