Job Description
Post Details
Title of Post:
Technician 2 – Downstream ( CF, IgG or Zenalb) Manufacturing
Pay Range:
A
Department/Directorate:
Production
Accountable to:
Team Leader
Main Job Purpose
To carry out specific processes within downstream purification and formulation in compliance with cGMP,
product licences, H&S standards, and KPI’s.
As the Team Technician of a designated process, you will set up and operate processes such as
Chromatography and Ultrafiltration, for which you will have a full operational understanding.
You will actively support an environment of continuous improvement ensuring that all quality and productivity
targets are achieved through the optimum use of resources in a safe environment. You will use effective
communication skills with all team members to ensure completion of the Production Manufacturing and filling
plans.
You will be able to analyse issues and effectively problem solve, in support of the Team Leader.
You will ensure that department H+S requirements are met.
Organisational Structure
Production Manager
Shift Manager
Team Leader
Technician 2
Key Duties and Responsibilities
Generic Technician Grade 2 Responsibilities
To develop the skills required to perform at a Technician Grade 2 level.
To have a full understanding of specific environment, process flows and equipment operation.
To have an understanding of the mechanical nature of specific equipment and perform minor
maintenance tasks such as assembly for use and periodic hygienic change of components
such as sample septums.
To have a basic understanding of utilities Including – HVAC operations, WFI, Purified Water
and demin, coolant systems and the Ethanol plan.
To manufacture products in compliance with approved procedures and in accordance with
agreed production programmes.
To maintain local and business KPI standards and requirements.
Help co-ordinate the activities of the section, liaise with other sections as necessary, help
organise the daily work operations as required.
Carry out staff training, ensure and maintain high standards of GMP and H&S.
To review of SOP’s, BPR’s and related documentation as required by the Team Leader.
To aid the Team Leader with specific investigations.
To inform the Team Leader of concerns related to the maintenance of working and
environmental standards and help ensure the working environment is maintained to the
required specification.
Ensure that equipment used is in compliance with any maintenance, calibration and validation
requirements.
Help ensure adequate and regular maintenance is carried out on all equipment and fabric
within the section.
To ensure that processes are maintained in compliance and control through cross shift
handovers that are performed through clear verbal communication in the area where the
process is running.
Specific Downstream Manufacturing Responsibilities
Have a working knowledge in one or more of the processes in downstream processing. For
example having a sufficient understanding of chromatographic techniques in production in
order to operate equipment in compliance unsupervised with the ability to solve problems.
To have an understanding of the principles of gas and liquid filtration and be able to
troubleshoot problems with filter testing and use.
To set up and operate automated and semi-automated manufacturing equipment as detailed
2
within the department training matrix including Ultrafiltration, centrifuge and Chromatography
processes as required.
To ensure that receipt and use of Process intermediates are carried out according to the
Production Plan.
To carry out Process Formulations and ensure that critical process samples are taken and
submitted correctly in accordance with the procedure and relevant IMS.
Carry out sterile transfers of final product to the Aseptic filling suite in time to meet the
scheduled filling plan.
To operate and trouble shoot Clean in Place systems for department specific static equipment.
To have a working knowledge of pH and conductivity monitoring and testing.
Acceptance and Review
Accepted
Manager Signature: .........................................Print Name: …………………… Date: …………………....
Jobholder Signature: ........................................Print Name: …………………… Date: …………………....
3