The company is a contract development and manufacturing organisation (CDMO) that specialises in advanced characterisation, Intellectual Property consulting, formulation development, analytical services and clinical manufacturing.
This is an exciting time for their business and they are looking for a Validation Engineer to join the team. To succeed in this fast-paced role, you must be able to manage changing priorities, be tenacious with a positive can-do attitude.
- To deliver the validation for new and existing GMP equipment and processes.
- To ensure that all equipment and processes are valid for GMP.
- To ensure that periodic review and periodic qualification are carried out in a timely manner.
- To ensure that validation lifecycle documents are maintained and audit ready.
- To ensure all validation activities are completed against regulatory expectations and local documentation.
- To perform / witness and approve calibration of critical instruments.
- To co-ordinate the validation team and ensure that activities are performed accordingly and in line with GMP.
- Have a formal qualification in validation and minimum of 3-5 years of experience performing validation activities.
- Have knowledge of GMP requirements to meet EU and US regulations.
- Have knowledge and experience of the qualification of clean rooms and utilities.
- Have experience of oral solid dosage equipment such as tablet press machinery
- Have engineering skills including calibration and maintenance requirements.
- Be Experienced in cleaning validation, CSV, Data integrity, EU V4 Chapter 5, Annex 11, Annex 13, Annex 15.
- Be a team player and be flexible.
- Have excellent time management skills.
- Have the capability to train and disseminate information to empower the team.
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