Senior Validation Specialist

7 days ago

Oxford, Oxfordshire, United Kingdom OSI Full time
About OSI

OSI is a UK-based diagnostics company dedicated to empowering individuals worldwide to access, understand, and act on their health, leading to healthier, happier, and longer lives.

We are pioneering the development of the Osler Origin, a portable lab that offers lab-quality performance in a rapid, low-cost, and easy-to-use manner. This innovative technology will serve all major healthcare settings globally, leveraging novel techniques and approaches for sample addition, microfluidic sample preparation, and electrochemical biosensing.

Job Summary

We are seeking a highly skilled Senior Validation Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for documenting and executing the site validation strategy, ensuring the qualification and re-qualification of facilities, utilities, equipment, computerized systems, cleaning, test methods, and process validation.

Key Responsibilities
  • Develop and implement a comprehensive validation strategy, aligning with regulatory requirements and industry best practices.
  • Collaborate with Quality Assurance to create lean and compliant Standard Operating Procedures (SOPs) governing validation activities and deliverables.
  • Own and drive the Validation Master Plan (VMP), ensuring timely and effective execution of validation tasks, sequencing, timelines, and resource allocation.
  • Lead a team of internal technical resources and facilitate external suppliers/service providers to establish a compliant validated state.
  • Foster a culture prioritizing employee health, safety, and well-being, demonstrating commitment to communicating, improving, and adhering to safety policies.
  • Develop and maintain relationships with cross-functional teams, including Product Development, Manufacturing Engineering, Supply Chain, Production, Facilities, and Quality.
  • Contribute to the selection and onboarding of new suppliers, evaluating vendor capabilities.
  • Produce reports providing data, commentary, and narrative to key stakeholders, senior management, and third parties as required.
  • Represent OSI at key program and design reviews, ensuring transfer and validation discipline.
  • Promote a work environment fostering openness, trust, communication, teamwork, empowerment, innovation, and satisfaction.
Requirements
  • Time-served Senior Validation Engineer/Manager with extensive experience in highly regulated industries.
  • Strong analytical skills, identifying risks to product, process performance, and compliance.
  • Proven ability to solve complex problems using established tools and methodologies.
  • Excellent communication and interpersonal skills, influencing decision-making and driving outcomes.
  • Strong organizational, planning, and follow-up skills, with the ability to hold others accountable.
  • Multi-tasking, prioritizing, and meeting deadlines in a timely manner.
  • Proven team leadership skills, setting goals, promoting personal accountability, and strong team engagement.
  • Driven and resilient, with the ability to work effectively in a fast-paced changing environment.
  • Experience in MedTech or ISO13485 or highly regulated sectors.
Preferred Qualifications
  • Degree (or equivalent) in a relevant engineering discipline.
  • Project management accreditation.
  • Formally trained in Lean/Six Sigma philosophies and toolkits.
What We Offer
  • Competitive benefits package, focusing on health and well-being.
  • 25 days holiday + bank holidays and a Christmas closure.
  • Annual Learning & Development budget 4% of your salary.
  • 12 days of Learning leave.
  • £500 Well-being allowance.
  • Private Medical Insurance (includes subsidised gym memberships).
  • 24/7 access to a GP.
  • Life Assurance - x4 annual salary.
  • Income Protection - 75% of your basic annual salary.
  • Private Travel Insurance.
  • Annual eye tests.
  • Cycle to work scheme.
  • Travel to work loan scheme.
  • Relocation assistance.
  • Volunteering leave.
  • Give as you earn - pre-tax salary donations to any UK charitable organisation.
  • Quarterly team building events and social events.
  • Enhanced maternity/paternity leave.

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