Job Title: Validation Engineer
- Calibration, Installation, Operation & Performance qualification (IOPQ) of Laboratory (Direct/indirect) equipment as per formal schedule including completion and filing of documentation, labels and application of labels.
- Maintenance of schedules: Calibration, Qualification, Preventative Maintenance & re-qualification of equipment.
- Maintain the Metrology Helpdesk generating reports & metrics and completing own assignments.
- Calibration of equipment – unscheduled, following repair or movement. Completion of
documentation, labels and application. Completion of Preventative Maintenance documentation, filing of service reports.
- Servicing and repair: quotes and details, correspondence with vendors, organisation of vendor visits or despatching equipment where necessary, documentation following completion of repair and re-calibration.
- Installation, Operation & Performance qualification (IOPQ) of new equipment into service as per ELL Validation protocol for acquisition of new equipment.
- Checking and signing off external certificates of calibration and generation internal certificates for same.
- Gathering information of external contractors, qualifications, procedures etc. and processing into the quality system.
- Periodic review of calibration, maintenance and qualification SOPs.
- Ensure Exceptions, internal audit observations; external audit observation, change control, and SOP periodic review are performed by you on time along with associated CAPAs.
- This person will ensure that all documentation is carried out on time, is accurate and legible and conforms to cGMP.
- They are responsible for their training, keeping their training sheets up to date and initiating
training where possible when free from work.
- Responsible for adhering to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
- As with all members of staff in ELL this person is responsible for ensuring that customers’ requirements are fully met and in so doing will be flexible to work in any area of the business as is required.
· Primary degree or equivalent in related discipline (Life Sciences, engineering)
· At least 1-5 years’ experience in a laboratory or GMP regulated environment is desirable; preferably with Calibration/Validation experience.
· Previous experience in GMP regulated environment.
· Awareness of pharmaceutical processes for equipment calibration and validation.
· Ability to work independently or as part of a team.
· Excellent technical writing, communication and organisational skills.
· Quality-oriented with the ability to consistently work to industry and client standards.
· Experience with documenting analytical data and writing reports.
· Passionate about quality and customer service.
· Experience in IOPQ & understanding on GAMP for Lab equipment would be desirable