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Senior Systems Validation Lead

  • Location:

    Galway

  • Contact email:

    khennessy@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    +3539145306

  • Job type:

    Full Time

  • Job ref:

    KHSSVL3110

  • Salary:

    Negotiable

  • Published:

    8 days ago

  • Contact email:

    khennessy@sigmar.ie

Job description

Senior Systems Validation Lead

 

Purpose:

The successful candidate will be expected to successfully execute projects and or validation programs. You will work to ensure conformance to quality systems, to liaise with various departments, and give guidance and lead more Junior Engineers. You will review documentation and ensure that validation work is being carried out as per company validation policies & procedures. You will be recognized as a leader within the organization, giving direction, inspiration and technical knowledge to fellow resources.

Operational Responsibilities

  • Creating and implementing new policies, procedures, guidelines or SOP’s based on company requirements and best internationally practices
  • Proactive in influencing the site procedures relevant to the industry specifications/ regulations.
  • Lead client discussion, effective in building client confidence.
  • Delivers complex projects using structured approaches
  • Deals with problems of increased complexity requiring considerable modification of techniques and application of new practices/ processes
  • Develops and delivers solutions that look beyond immediate issues
  • Developing and reviewing validation plans, test protocols, test data and test reports
  • Independently designs, executes, interprets and reports results on work
  • Is expected to solve the majority of problems that arise with little supervisory input
  • Demonstrates ability to address problems of high technical complexity
  • Co-ordinates to the design and implementation of validation activities and deliverables on projects
  • Managing and conducting Risk Assessments
  • Demonstrates commercial awareness/ cost consciousness
  • Keeps Validation Manager updated of all critical validation activities
  • Co-ordinating routine Internal Quality Audits of the organization to ensure compliance, be proactive in resolving issues which may arise

Team Management Responsibilities

  • To mentor and motivate Validation Engineers to consistently deliver on all Validation requirements for customer projects
  • To provide guidance and training to staff across various functions on Validation related items
  • To escalate issues to the Compliance Director in a timely manner and where appropriate
  • To encourage team participation in any health & wellbeing initiatives in the Company
  • To promote and demonstrate the Company Values
  • To conduct regular team meetings and ensure the team are updated on any changes to procedures and policies
  • To make all personnel on the team aware of all SL Controls Standard Operating Procedures in conjunction with our HR induction procedure
  • To be aware of the movements of all team members i.e. holidays, sick days etc. All such planned and unplanned absences of SL Controls employees must be communicated to the HR department in a timely and efficient manner
  • To draft and commit individual Work Compass Performance Plans in agreement and collaboration with team members using the appropriate Goal & Competences Library Groups
  • Responsible for the group annual and/or mid-year performance management reviews and quarterly check ins via Work Compass in conjunction with SL Controls HR department

Requirements

  • 7+ years’ experience within Validation Engineer role (mainly computer validation) in the Pharmaceutical or Healthcare industry
  • Previous team management experience
  • Display strong investigative or technological orientation with independence.
  • Displays strong initiative and commitment
  • Experience of GxP Computerized Systems
  • Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerized System Validation, ISO quality requirements
  • Excellent knowledge of the GAMP5 guidelines
  • Excellent understanding of validation concepts and documentation

To apply for this position please contact Kim Hennessy at Sigmar Recruitment T: +353 91 455306 E: khennessy@sigmar.ie    

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