Computer Systems Validation Engineer

5 days ago

Swadlincote, United Kingdom Healthnet Homecare Full time

HealthNet Homecare are specialists in delivering homecare services for patients, from medical deliveries to nursing support for patients in their own homes.

Working with over 180,000 patients across numerous different therapy areas, our dedicated team offer support to patients with rare and orphan diseases right through to more common conditions. Our aim is to make patients' lives easier by taking the stress out of managing their medication and ensuring they are confident they are in safe hands with HealthNet.

We are looking for a Computer Systems Validation Engineer to join our IT department.

If you are a passionate and caring individual, seeking a role with a mission statement you can truly get behind, where you can help to make a difference to patients' everyday lives, then this is the opportunity for you

Main Responsibilities

We are seeking an experienced and dedicated Computer System Validation (CSV) Engineer to join our dynamic team. The CSV Lead will be responsible for overseeing the validation processes of computerized systems used within our operations, ensuring compliance with regulatory standards such as MHRA, FDA, EMA, and other applicable global regulations. The ideal candidate will have a strong background in pharmaceuticals, biotechnology, or related fields, with expertise in system validation, quality assurance, and software lifecycle management.

  • Validation Planning and Execution: Develop comprehensive validation strategies and plans for computer systems, including defining the scope, approach, resources, and schedules.
  • Regulatory Compliance: Ensure all computer system validations are conducted in accordance with relevant regulatory requirements and industry best practices.
  • Documentation Management: Lead the creation and review of all validation documentation, including validation plans, test protocols, and final reports.
  • Coordination: Coordinate with cross-functional teams including IT, Quality Assurance, and Operations to ensure alignment on project goals.
  • Risk Management: Conduct risk assessments and implement risk management strategies throughout the validation lifecycle.
  • Process Improvement: Continuously improve validation processes and procedures by implementing innovative approaches and adopting new technologies.
  • Stakeholder Engagement: Serve as the main point of contact for all matters related to computer system validation. Communicate effectively with internal stakeholders and external auditors or inspectors.
  • Training: Develop and deliver training materials related to CSV practices to ensure team and company-wide awareness and understanding.

Communication and problem solving

  • To work with the IT Project Management Team and Quality team in validating systems, informing Project Planning, and ensuring the validation tasks are carried out in a timely manner
  • To encourage pro-active discussions with IT and Quality
  • To contribute regularly to discussions regarding internal process and validation improvements

Company best practice

  • To stay aware of compliance and regulatory standards
  • To freely share knowledge, insight, best practice and ideas
  • To assist by offering strategic and technical advice for anyone working on these projects

What experience and skills are we looking for?

  • Detail-oriented with a commitment to accuracy and quality.
  • Proactive in identifying issues and capable of working autonomously to resolve them.
  • Passionate about improving systems and processes through innovation.
  • Strong ethical standards and a high level of personal integrity.
  • Experience at advising key stakeholders

Essential

  • Proven leadership skills and experience managing validation teams.
  • Excellent project management skills, with the ability to manage multiple projects simultaneously.
  • Strong analytical and problem-solving skills.
  • Exceptional communication and interpersonal skills, capable of working constructively with diverse teams.

Qualifications?

  • Bachelor's in Computer Science, Engineering, Life Sciences, or related field.
  • At least 2 years of experience in computer system validation within a regulated environment, preferably in pharmaceuticals or biotechnology.
  • Strong knowledge of GAMP 5 guidelines, 21 CFR Part 11, Annex 11, and other relevant regulatory standards.
  • Proven leadership skills and experience managing validation teams.
  • Excellent project management skills, with the ability to manage multiple projects simultaneously.
  • Strong analytical and problem-solving skills.
  • Exceptional communication and interpersonal skills, capable of working constructively with diverse teams.

What we offer:

  • Competitive salary structure
  • 25 days holiday + bank holiday
  • Pension Scheme
  • Ongoing training and development
  • Professional registration fees paid
  • Employee Assistant Programme including 24/7 hour access to remote GP appointments.
  • Refer a friend scheme
  • Uniform provided
  • Kit bags for all Homecare Nurses
  • Eyecare Vouches
  • Perks and benefits via Perkbox
  • Long service awards.

If the role sounds of interest, and you want to be a part of a company who truly places our patients at the heart of everything we do, please fee

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