Validation Engineer Medical Device Keele

1 month ago


NewcastleunderLyme, United Kingdom Adecco Full time

**Validation Engineer (Medical Device) Keele**

I am currently recruiting for a Validation Engineer to join an international medical device company that engineers, manufactures and markets world leading products.

**Role responsibilities**:
The Validation Engineer role will primarily be accountable for the validation for Processes, Facilities, Equipment, Cleaning, Computer Software Validations (CSV) and IT projects, in both a Medical Device and Pharmaceutical (cGMP) environment, including theSite Validation Master Plan (SVMP) and maintenance of such plan.
- Prepare and issue Site Validation Master Plans (SVMP), Summary Reports and other required documentation for a validation exercise. Organise and lead validation activities to provide an effective validation service.
- Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans, objectives, and schedules.
- Provide validation leadership to ensure that all operations are carried out in compliance with regulatory and company requirements. Provide validation support and advice to other areas of the business as required.
- Ensure projects relating to processes, facilities, equipment, cleaning, and CSV/IT validation are in compliance with regulatory and company requirements.
- Promote effective working relationships and ensure they are maintained through the validation working party. Support a continuous improvement culture within the business.
- Provide leadership, guidance, and direction to staff consistent with ISO13485, 21 CFR 820, and appropriate Pharmaceutical requirements.
- Develop work plans, assign tasks, and supervise teams to achieve the overall site validation requirements.
- Ensure staff have required knowledge and training when performing validation activities on department, site, processes, and procedures
- Address site validation gaps via generation and completion of Site Validation Master Plans
- Maintain site validation status according to regulatory requirements
- Identify resource requirements and rate limiting steps within the Site Validation Master Plan

**Role requirements**:

- Minimum 5 years Validation experience within Pharmaceutica/Medical Devices, including cleaning, analytical methods, lab equipment, computer system validation and re-qualification
- Manufacturing process validation experience preferable, including the validation of new processes and changes to established processes using the lifecycle approach to validation
- Proficient in Minitab or other alternative system and software packages Knowledge of Quality Management Systems
- Level 6 within a science regulated industry or relevant experience
- Level 5 in Leadership Management



  • Newcastle-under-Lyme, United Kingdom Adecco Full time

    **Validation Engineer (Medical Device) Keele, £50,000-£65000** I am currently recruiting for a Validation Engineer to join an international medical device company that engineers, manufactures and markets world leading products. **Role responsibilities**: The Validation Engineer role will primarily be accountable for the validation for Processes,...


  • Newcastle upon Tyne, United Kingdom Keele University Full time

    **Post ref**: KU00003177 **Fixed Term for 12 Months (in the first instance)** Agile working (blend of home and office based)/ Arrangements for job share would be considered. This post represents an exciting opportunity for an ambitious individual to join the public/global health within Keele University’s School of Medicine. The public health/global...


  • Newcastle-under-Lyme, United Kingdom Alliance Medical Full time

    **About This Role**: We have an exciting opportunity for a Customer Liaison Officer to join our Radiopharmacy team, based in Keele, supporting our national network of 5 Radiopharmaceutical Production Units and the customers we serve. Situated in the Keele University Science and Innovation Park, the site supplies radiopharmaceuticals to PET (Positron...

  • Qualified Person

    4 weeks ago


    Newcastle-under-Lyme, United Kingdom Alliance Medical Full time

    **About the role**: We have an exciting opportunity for a Qualified Person to join us at Alliance Medical. This is a full time role working 40 hours a week on a permanent basis. We are ideally looking for an experienced Qualified Person, with management experience and responsbility for a Quality Management System. It is preferable that you have experience...


  • Wotton-under-Edge, United Kingdom Renishaw PLC Full time

    A vacancy has arisen for an experienced Medical Quality Engineer.The successful candidate will be required to provide Quality Engineering support for manufactured or subcontract manufactured current and development products, these include a drug delivery system (neuroinfuse), surgical planning software (neuroinspire) and devices supporting neurosurgery.Key...


  • Wotton-under-Edge, United Kingdom Renishaw PLC Full time

    A vacancy has arisen for an experienced Medical Quality Engineer.The successful candidate will be required to provide Quality Engineering support for manufactured or subcontract manufactured current and development products, these include a drug delivery system (neuroinfuse), surgical planning software (neuroinspire) and devices supporting neurosurgery.Key...


  • Wotton-Under-Edge, South West, United Kingdom Renishaw PLC Full time

    A vacancy has arisen for an experienced Medical Quality Engineer.Have you got the right qualifications and skills for this job Find out below, and hit apply to be considered.The successful candidate will be required to provide Quality Engineering support for manufactured or subcontract manufactured current and development products, these include a drug...


  • Newcastle under Lyme, Staffordshire, United Kingdom Alfa Laval Full time

    Alfa Laval is looking for aTrainee Project Engineer ( Business Placement Year ) At Alfa Laval, we always go that extra mile to overcome the toughest challenges. Our driving force is to accelerate success for our customers, people and planet. You can only achieve that by having dedicated people with a curious mind. Curiosity is the spark behind great ideas....


  • Newcastle-under-Lyme, United Kingdom Alfa Laval Full time

    Alfa Laval is looking for aTrainee Project Engineer ( Business Placement Year ) At Alfa Laval, we always go that extra mile to overcome the toughest challenges. Our driving force is to accelerate success for our customers, people and planet. You can only achieve that by having dedicated people with a curious mind. Curiosity is the spark behind great ideas....


  • Newcastle-under-Lyme, United Kingdom University Hospitals of North Midlands NHS Trust Full time

    An exciting opportunity has arisen at the University Hospital of North Midlands to join the Stroke team working at Royal Stoke site. We are looking for an individual to train and develop within our Stroke services. Dr. Indira Natarajan's secretary Pam Breeze can be contacted on 01782 679483 for an informal discussion. Please see attached job pack for...

  • Systems Architect

    15 hours ago


    Newcastle, United Kingdom The Mullings Group Full time

    The OpportunityAre you the right candidate for this opportunity Make sure to read the full description below.Our client is a privately held, development stage startup on the cutting edge of innovation in neurological therapy. This company focused on medical implantable technologies for neurological application and first generation BCI (Brain Computer...


  • Newcastle-under-Lyme, United Kingdom Alliance Medical Full time

    **About The Role**: Due to significant expansion, we have a fantastic opportunity for a Quality Assurance Officer to join our Radiopharmacy Quality Team. If you have experience in Quality Assurance within a GMP environment; good organisation skills; proactive with a can-do attitude; detail-focused and time-oriented; an excellent grasp of problem solving and...


  • Newcastle upon Tyne, United Kingdom Hengandhurst Full time

    Medical Device / Sales If you're a commercially savvy medical device sales professional, I'd love to hear from you. Strong understanding of the hospital structure and sales process Experienced medical devices/surgical rep required Great team culture and development opportunities This company is a global medical device company that brings...


  • Newcastle-under-Lyme, United Kingdom Newcastle Under Lyme Borough Council Full time

    **Salary**: Grade 6 - £24,496 to £26,845 per annum (2023 pay award pending). Potential to earn £27,071 to £29,666 per annum via enhancements / allowances. **Hours**: 37 hours per week. **Contract**: Permanent. **Location**: Based at our depot on Knutton Lane in Newcastle-under-Lyme. **About the job**: Our team delivers high quality services, with a...


  • Newcastle upon Tyne, United Kingdom Hengandhurst Full time

    Territory Manager | Surgical | Newcastle Medical Device / Sales Medical Device / Sales Exciting full time role, with a well-recognised medical technology company. Innovative products and well recognised brand Exciting time to join this medical technology company. In their area of surgical specialisation, they pride themselves on innovative...


  • Newcastle upon Tyne, United Kingdom Hengandhurst Full time

    Territory Manager | Surgical | Newcastle Medical Device / Sales Medical Device / Sales Exciting full time role, with a well-recognised medical technology company. Innovative products and well recognised brand Exciting time to join this medical technology company. In their area of surgical specialisation, they pride themselves on innovative...

  • Electrical Engineer

    7 days ago


    Newcastle-under-Lyme, United Kingdom Alfa Laval Full time

    Alfa Laval UK&I are currently looking for an Electrical Engineer to join our Projects Team At Alfa Laval, we always go that extra mile to overcome the toughest challenges. Our driving force is to accelerate success for our customers, people and planet. You can only achieve that by having dedicated people with a curious mind. Curiosity is the spark behind...


  • Newcastle-under-Lyme, United Kingdom Newcastle and Stafford Colleges Group Full time

    **ASSESSOR IN ELECTRICAL INSTALLATION** **Full-time - 37 hours per week** **Location: - Newcastle-under-Lyme & Stafford College** **Salary: Total Overall package of up to £44,803 as follows**: Salary - £26,609 - £36,132 Employer Pension Contributions - £6,386 - £8,671 **Holiday: - 40 Days per year, rising to 45 days following 5 years’...

  • Shift Engineer

    5 days ago


    Newcastle-under-Lyme, United Kingdom Broxap Full time

    MAINTENANCE ENGINEER / NEWCASTLE UNDER LYME / £35,000 TO £45,000 PER ANNUM + BENEFITSAn exciting opportunity has arisen for an experienced and enthusiastic Maintenance Engineer to join our existing maintenance team.Broxap is a family owned engineering business based in Newcastle under Lyme, Staffordshire, established in 1946. We are amongst the market...


  • Newcastle Upon Tyne, United Kingdom Real Staffing Full time

    Our client is a progressive MedTech company passionate empowering the world to control disease and reduce suffering. They are looking to solve real-world problems by creating molecular diagnostic solutions for the point of need, for anyone, anywhere. The Senior Mechanical Engineer will develop engineering solutions for research and commercial development...