Validation and Process Specialist

4 weeks ago

Blackpool, Blackpool, United Kingdom HCLTech Full time
Job Summary

We are seeking a highly skilled and detail-oriented Validation & Process Engineer to join our team at HCLTech. The ideal candidate will be responsible for preparing and executing equipment validation protocols, performing process characterization, updating key documents like BOMs and DMRs, and supporting product lifecycle management (PLM) activities. This role plays a critical part in ensuring that equipment and processes meet the highest standards of quality and compliance.

Key Responsibilities
  1. Equipment Validation Protocols
    • Develop and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment validation.
    • Ensure that all validation activities comply with industry standards and regulatory requirements.
  2. Test Method Validations
    • Create and implement test method validation protocols to ensure reliable and reproducible testing methods.
    • Collaborate with quality, R&D, and manufacturing teams to ensure accurate execution and results analysis.
  3. Process Characterization and Design of Experiments (DoE)
    • Perform process characterization and identify key process variables that influence performance.
    • Design, execute, and analyze experiments using Design of Experiments (DoE) methodologies to optimize processes and equipment performance.
  4. BOM and DMR Updates
    • Maintain and update Bill of Materials (BOM) and Device Master Record (DMR) documents to reflect any changes in processes, materials, or equipment.
    • Ensure all documentation is current and aligns with company standards and regulatory guidelines.
  5. Support in Protocol Execution and Report Generation
    • Assist in the execution of validation and test protocols.
    • Prepare detailed validation reports and ensure that all findings, data, and results are properly documented.
  6. PLM System Activities
    • Support Product Lifecycle Management (PLM) activities including Change Orders (CO), report routing, and follow-up on approvals.
    • Ensure all necessary approvals are obtained and documentation is updated within the PLM system.
Required Qualifications
  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • 3+ years of experience in equipment validation, process characterization, or a similar role in the medical device, pharmaceutical, or manufacturing industry.
  • Strong knowledge of validation processes and protocols (IQ/OQ/PQ).
  • Experience with Test Method Validation (TMV) and statistical analysis.
  • Familiarity with Design of Experiments (DoE) techniques for process optimization.
  • Knowledge of PLM systems and Change Order (CO) processes.
  • Strong attention to detail and ability to document protocols and reports clearly.
Preferred Qualifications
  • Experience in regulated industries such as medical devices or pharmaceuticals.
  • Knowledge of ISO 13485, FDA regulations, or other relevant regulatory standards.
  • Proficiency in software tools like Minitab, JMP, or similar for statistical analysis.
  • Experience with BOM and DMR management.
Skills and Competencies
  • Excellent analytical and problem-solving skills.
  • Strong organizational skills with the ability to manage multiple tasks simultaneously.
  • Effective communication and collaboration skills, with the ability to work across departments.
  • Ability to work independently and take ownership of complex projects.
  • High attention to detail and a commitment to producing quality work.

  • Care Support Specialist

    2 weeks ago

    Blackpool, Blackpool, United Kingdom Prestige Nursing and Care Full time

    Job DescriptionWe are seeking a skilled and compassionate Care Support Specialist to join our team at Prestige Nursing & Care.About the RoleAs a Care Support Specialist, you will be responsible for providing high-quality care and support to our clients in their own homes. This will involve assisting with daily living tasks, such as bathing, dressing, and...

  • Quality Assurance Specialist

    2 weeks ago

    Blackpool, Blackpool, United Kingdom Employment Solutions Ltd Full time

    Quality Assurance SpecialistAt Employment Solutions Ltd, we are seeking a skilled Quality Assurance Specialist to join our team as the new Quality Engineer. This role involves comprehensive management of quality assurance activities across the full life cycle of products within a specific market sector. The Quality Assurance Specialist ensures strict...

  • Quality Assurance Specialist

    2 weeks ago

    Blackpool, Blackpool, United Kingdom Employment Solutions Ltd Full time £35,000 - £45,000

    Employment Solutions Ltd is seeking a Quality Assurance Specialist to join their team in the Blackpool area.This role involves comprehensive management of quality assurance activities across the full life cycle of products within a specific market sector.The Quality Assurance Specialist ensures strict compliance with relevant quality standards, thereby...

  • Security Specialist

    2 weeks ago

    Blackpool, Blackpool, United Kingdom Kingdom Services Group Ltd Full time

    Kingdom Services Group Ltd is seeking a skilled Security Specialist to support our in-store security teams across various locations. The ideal candidate will be based in the Fylde Plain area and will be responsible for patrolling and monitoring premises and personnel to maintain a safe and secure environment for customers and employees.The successful...

  • Process Improvement Project Manager

    4 weeks ago

    Blackpool, Blackpool, United Kingdom Ipsum Full time

    About the RoleWe are seeking a highly skilled Project Manager to join our team at Ipsum, a leading provider of specialist utility and infrastructure solutions. As a Project Manager for Business Improvement, you will play a key role in driving process excellence and business transformation across our organisation.Key ResponsibilitiesManage complex projects...

  • Process Improvement Project Manager

    4 weeks ago

    Blackpool, Blackpool, United Kingdom Ipsum Full time

    About the RoleWe are seeking a highly skilled Project Manager to join our team at Ipsum, a leading provider of specialist utility and infrastructure solutions. As a Project Manager for Business Improvement, you will play a key role in driving process excellence and business transformation across our organisation.Key ResponsibilitiesManage complex projects...

  • Process Improvement Project Manager

    3 weeks ago

    Blackpool, Blackpool, United Kingdom Ipsum Full time

    About IpsumWe are a leading customer service focused provider of specialist utility and infrastructure solutions, operating on both public and private networks.Our vision is to be the leading customer service focused provider of specialist utility and infrastructure solutions, operating on both public and private networks.Job SummaryWe are looking for a...

  • Senior Process Improvement Specialist

    1 month ago

    Blackpool, Blackpool, United Kingdom E3 Recruitment Full time £58,000 - £70,000

    Senior Process Improvement EngineerWe are seeking a highly skilled Senior Process Improvement Engineer to join our team at a globally leading Chemical company based in the Blackpool area. This is a permanent position with a competitive salary of between £58,000 - £70,000 per annum.The successful candidate will be part of one of the world's largest chemical...

  • Senior Process Improvement Specialist

    1 month ago

    Blackpool, Blackpool, United Kingdom E3 Recruitment Full time £58,000 - £70,000

    Senior Process Improvement EngineerWe are seeking a highly skilled Senior Process Improvement Engineer to join our team at a globally leading Chemical company based in the Blackpool area. This is a permanent position with a competitive salary of between £58,000 - £70,000 per annum.The successful candidate will be part of one of the world's largest chemical...

  • Part-time Engineering Specialist

    1 month ago

    Blackpool, Blackpool, United Kingdom HCLTech Full time

    Job DescriptionThis role plays a critical part in ensuring that equipment and processes meet the highest standards of quality and compliance.Key Responsibilities:Develop and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment validation.Ensure that all validation activities...

  • Part-time Engineering Specialist

    1 month ago

    Blackpool, Blackpool, United Kingdom HCLTech Full time

    Job DescriptionThis role plays a critical part in ensuring that equipment and processes meet the highest standards of quality and compliance.Key Responsibilities:Develop and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment validation.Ensure that all validation activities...

  • Dental Care Specialist

    2 weeks ago

    Blackpool, Blackpool, United Kingdom beBee Professionals Full time £50,000 - £80,000

    We are seeking a skilled Dental Care Specialist to provide high-quality dental care to our patients. The ideal candidate will have a degree in Dentistry and a valid license to practice in Ireland.Key Responsibilities:Perform routine dental procedures, including examinations, cleanings, and fillings.Provide patient education on maintaining good oral...

  • Nurse Specialist

    2 weeks ago

    Blackpool, Blackpool, United Kingdom Care Supply Pool Full time

    Job Title: Registered NurseJob Summary:Care Supply Pool is a healthcare recruitment business that provides staffing support to healthcare organisations across the UK, specialising in the health, social care, nursing, and related sectors. We are currently seeking a skilled and compassionate Registered Nurse to join our team.Key Responsibilities:* Provide...

  • Complex Care Support Specialist

    2 weeks ago

    Blackpool, Blackpool, United Kingdom Prestige Nursing and Care Full time

    Job OverviewPrestige Nursing & Care is seeking a dedicated and compassionate Complex Care Assistant to join our team. As a Complex Care Assistant, you will provide high-quality care and support to clients with complex needs in their own homes.Key Responsibilities:Prompting and administering medication as requiredAssisting with the preparation of meals and...

  • Senior Process Improvement Specialist

    1 month ago

    Blackpool, Blackpool, United Kingdom E3 Recruitment Full time £58,000 - £70,000

    Senior Process Improvement EngineerWe are seeking a highly skilled Senior Process Improvement Engineer to join our team at a globally leading Chemical company based in the Blackpool area. This is a permanent position with a competitive salary of between £58,000 - £70,000 per annum.The successful candidate will be part of one of the world's largest chemical...

  • Senior Process Improvement Specialist

    1 month ago

    Blackpool, Blackpool, United Kingdom E3 Recruitment Full time £58,000 - £70,000

    Senior Process Improvement EngineerWe are seeking a highly skilled Senior Process Improvement Engineer to join our team at a globally leading Chemical company based in the Blackpool area. This is a permanent position with a competitive salary of between £58,000 - £70,000 per annum.The successful candidate will be part of one of the world's largest chemical...

  • Mental Health Nurse Specialist

    3 weeks ago

    Blackpool, Blackpool, United Kingdom Service Care Solutions - Healthcare Full time

    Job Title: Registered Mental Health NurseService Care Solutions is a leading healthcare recruitment agency connecting dedicated professionals with enriching opportunities.Role and Responsibilities:Conduct ongoing assessments for young people in crisis, completing necessary paperwork and referrals.Collaborate with partner agencies, such as children's services...

  • Nurse Specialist

    3 weeks ago

    Blackpool, Blackpool, United Kingdom Care Supply Pool Full time

    Job Title: Registered NurseJob Type: Full-time, Part-timeLocation: Blackpool, LancashireJob Description:We are seeking a highly skilled and compassionate Registered Nurse to join our team at Care Supply Pool. As a Nurse, you will have the opportunity to work in a variety of settings, including mental health hospitals, NHS, residential homes, nursing homes,...

  • Acute Medicine Specialist

    3 weeks ago

    Blackpool, Blackpool, United Kingdom Blackpool Teaching Hospitals NHS Foundation Trust Full time

    About the RoleWe are seeking a highly skilled and experienced Acute Medicine Consultant to join our team at Blackpool Teaching Hospitals NHS Foundation Trust. As a key member of our Division of Integrated Medicine and Emergency Care, you will play a vital role in providing high-quality patient care and leading our services as the new Head of Acute...

  • Transportation Specialist

    3 weeks ago

    Blackpool, Blackpool, United Kingdom Blackpool and The Fylde College Full time

    Transportation SpecialistWe are seeking a reliable and safety-conscious Transportation Specialist to join our team at Blackpool and The Fylde College. As a Transportation Specialist, you will be responsible for safely transporting our college sports teams between campuses and to games, allowing them to compete in competitive fixtures across the county.Key...