JOB DESCRIPTION

JOB TITLE: /

Process Validation duction Development Engineer

NAME: /

Daniel Rakauskas

DEPARTMENT: /

Engineering

REPORTINGTO: /

Daniel RakauskasSenior Engineer/Operations Manager

REVIEW DATE: / April 08 / SALARY REVIEW DATE: /

April 08

JOB OVERVIEW: / As a member of the Engineering Department, to fulfil the role of identifying, To assist the Senior Engineer in his role of identifying, implementing and validating the most cost effective means of developing all production processes and equipment within Intersurgical Wokingham. This could either be by purchasing capital equipment or assisting with design, and building of equipment using internal resources.

RESPONSIBILITIES:

  1. As a member of the Engineering Department, to assist To aid the Operations Manager and Senior Engineer in the function of improving efficiency and quality of production processes within all areas of Intersurgical Wokingham.
  1. To assist in the analysis of the most cost effective means of improving production processes, either by utilising external or internalexisting resource.

The most relevant example of this where production equipment was concerned over the past year, was my involvement with Paramount Packaging during the Validation phase of the Fuji Packaging Machine. The other main area of improving the production process is leading the Bioburden action team, in order to monitor & improve on hygiene aspects in day-to-day production activities.

  1. To make sure that full pre-production trials are done prior to accepting any new equipment into the production environment. This will include carrying out full validation reports for all new items of equipment, and revalidation arising from changes to existing equipment, this to be carried out meeting all the requirements of the Intersurgical’s Internal Quality SystemDepartment.
  1. To also make sure that any equipment from point 3 is continually monitored for process output, efficiency, and scrap levels, and reporting this data as a continual process control report.
  1. Acting as a member of the Engineering Department assist with the task of integrating all production equipment, and feeding the data back to a central source, monitoring all equipment to meet point 4.

1.To be responsible for the implementation of improved or new equipment, making sure that documentation is in place, as laid out in Intersurgical’s quality system, and that all training and maintenance requirements are also met. This requirement will also apply to the training of newly appointed personnel.

Again, the best example of this is the Fuji Packaging Machine.

To also make sure that any equipment from point 3 is continually monitored for process output, efficiency, and scrap levels, and reporting this data as a continual process control report.

I carried out extensive monitoring of reject levels to demonstrate the long-term performance of the Fuji Packaging Machine, drawing attention to situations where optimisation was still required.

Assisting the Senior Engineer with his task of integrating all production equipment, and feeding the data back to a central source, monitoring all equipment to meet point 4.

I have had less involvement with production machinery this year, instead focusing on the Bioburden cleaning & monitoring activities in Wokingham Production. This has involved managing the data collection programme for the Biotrace Luminometers we use.

To be assist Senior Engineer with the responsibility of the implementation of improved or new equipment, making sure that full documentation as required by the Intersurgical’s quality system, and that all training and maintenance requirements are also met.

I have carried out training with the majority of Production personnel in Bioburden Awareness, as well as giving detailed training in the use of the hygiene monitoring equipment used on the Bioburden monitoring programme.

  1. To also carry out risk assessment on new or existing equipment, making sure that all operators parties are aware of and comply with all Health and Safety requirements, and that they are all fully trained in the equipment’s safe operation.

Following up Intersurgical’s requirements for health & safety with regard to the Automatic Hand Washing System, required liaison with the manufactures, ‘Meritech Inc’ based in the US. Training on use of this piece of equipment was carried out during the Bioburden Awareness training sessions.

  1. To make sure that if assist the Senior Engineer with the procurement ofment of equipment is required for engineering projects, that it is done meeting all Intersurgical’s internal procedures, and by keeping abreast of new and developing technologies within industry, make sure that the equipment is the most suitable that the market can offer, whilst ensuring that it meets the requirements of the current statutes and legislation..

My main involvement of sourcing new equipment has been with the bioburden monitoring instrumentation, including more recently, investigating microbial air sampling equipment. I feel that I have built up a good working relationship with Biotrace Fred Baker & it’s representatives, having come into face-to-face contact with them during their visits to Intersurgical.

  1. To act as a liaison between other departments on projects that the engineering department is planning or is undertaking especially equipment’s implementation into the production environment.
  1. To act as a liaison between the R&D department and production resources to ensure that trial requests are fully documented and carried out in a timely and professional manner and these trials are carried out meeting all the requirements of the Intersurgical Internal Quality System.
  1. To make sure that any projects that are undertaken are maintained to within agreed budget levels and timescales, and that it is reported using current Intersurgical’s reporting tools. To make sure that any projects that are undertaken are maintained on the project development database reflecting budgets and timescales, and updates are entered to reflect current statuses of the

project.

2.To make sure that any projects that are undertaken are maintained to within agreed budget levels and timescales, and that it is reported using current Intersurgical’s reporting tools.

My main area of involvement outside of Engineering has been with the QA Department & Production team. I have listened closely to feedback from operatives in the Production department during bioburden awareness training, and worked closely with QA helping them to get the best out of the hygiene monitoring equipment and it’s reagents.

1.To also be responsible for making sure all project plans for engineering projects are fully maintained. Monitoring things such as times scale and budgets. Making sure that any deviation to either the time scale or the budget is reported at review meetings.

To this end, my involvement with the hygiene monitoring programme, ensuring that the quantities of it’s consumables fits our hygiene sampling regime and sourcing additional test equipment for ad-hoc studies demonstrates my ability to plan & organise resources effectively.Making sure that all production design review meetings are fully documented, and maintained in the appropriate manor, as laid down by the management or Quality Department.

  1. Any other reasonable tasks that may, from time to time, be required by the company.

Project List:

Main areas of work since last appraisal have been:-

Overseeing Bioburden Cleaning & Monitoring Programme

Conducting Bioburden Awareness Training

Investigations into hygiene aspects of Wokingham Production by means of hygiene monitoring

Procurement of Automatic Hand Washer System & evaluation thereof

Validation Of Fuji Packaging Machine

Investigation of alternative supplier (Hygiena) for reagents for hygiene monitoring

Investigating technology available for microbial air sampling

Re-thinking the Validation Master Plan for Wokingham

EMPLOYEEMANAGER

DATE: 02-06-08