Project Validation Lead

Plasma Operations committed to providing a continuous supply of reliable, high quality plasma-derived products worldwide, supporting both healthcare professionals and patients every day.

Location: Hertfordshire
Sector: Life Sciences
Job Type: Permanent
Remuneration: £61,067 - £80,000
Published:
Expiry Date: 02/01/2022
Duration: N/A
Start Date: 04/01/2022

Person Specification

  • Organised
  • Professional
  • Confident
  • Collaborative
  • Transparent
  • Responsive

Job Role & Responsibilities

  • Manage the planning and implementation for all validation activities associated with the Line project including main filling line, facility and utilities and all associated ancillary equipment and processes
  • Identify and organise the resources needed to deliver the validation requirements for the project to achieve completion of the project as planned
  • Proactively manage the performance of the external contractors operating under your remit
  • Provide specialist Validation technical expertise and guidance to the Line Project in the management and resolution of validation risks associated with the ProjectAct as site subject matter expert with respect to the Filling Line
  • Lead problem solving investigations associated with validation non-compliances
  • Application of risk and science based tools to drive execution strategies and support issue resolution
  • Responsible for the implementation of commissioning, qualification and validation in coordination with the Quality and Sterility Assurance groups
  • Lead cross-functional teams in the resolution of technical / validation risks / issues
  • Work with customers and stakeholders to effectively manage expectations and ensure timely completion of tasks related to the Filling Line programme
  • Monitor industry trends and ensure implementation of best practice
  • Ensure personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements
  • Ensure that the equipment/facility meets regulatory requirements at all times with a target of zero impact to routine operations and project deadlines
  • Ensure that risks to product quality, patient safety and/or data integrity throughout the validation lifecycle are understood, transparent and managed through the application of a quality risk management approach
  • Continuously improve validation processes to eliminate waste, improve effectiveness and efficiency, whilst in alignment with industry best practices and stakeholder requirements.
  • Integrate with, and interact across, all relevant functions including Engineering, Quality Assurance, Manufacturing and/or Supply Chain to ensure compliant validation service delivery to the assets related to the Line programme
  • Maintain an ongoing dialogue with Validation Management to ensure coordination of Line activities with site validation requirements and that overall validation resources are effectively deployed

Qualifications

  • Education
    • Degree level qualification, science or engineering discipline or equivalent
  • Skills and Experience
    • Experience of the Validation of Sterile Filling Operations. Experience of Integrated Filling Lines very desirable
    • Experience of Facility/Utility Validation
    • Experience of Validation of Freeze Dyers desirable
    • Highly experienced in problem solving technical issues associated with Filling line/facility processes
    • A good understanding of risk and science based tools and their practical application in driving execution strategies
    • Communication (including the ability to understand, summarise and communicate complex issues) be it by phone, email, teleconference, face to face or presenting is a key skill for this role
    • Significant recent leadership and management experience
    • The ability to influence and promote positive behaviours and performance

Benefits

  • Life Insurance
  • 10% Bonus
  • 6% Pension
  • 25 days holiday

A customer focused employment business working across a range of specialist sectors, we introduce exceptional people to extraordinary companies.  Providing contract, permanent and search recruitment, we treat employers and candidates as equals, tailoring our services to suit their unique requirements whilst supporting all parties throughout their employment journey.

  • Accepted file types: pdf, docx, doc, odt, xls, xlsx, png, jpg, Max. file size: 8 MB.
    No file chosen
  • This field is for validation purposes and should be left unchanged.