Validation Engineer

Employer
Location
Loughborough, England
Salary
GBP30000 - GBP50000 per annum
Posted
Aug 26, 2016
Closes
Sep 23, 2016
Ref
363228
Contact
Alex Langrish
Result Type
Jobs
Position Type
Permanent
Hours
Full Time

As part of the team you will be responsible for a range of activities including Facility, Equipment and Utility Qualification, Computerised System Validation (CSV), Process and Packaging Validation, Cleaning Validation and Shipping Qualification. In addition you will provide technical input to Master Batch Records, SOPs and assess planned and unplanned changes as a technical quality expert.

The role will require occasional travel, including site visits to Northern Ireland.

JOB SPECIFIC RESPONSIBILITIES:

1. Actively assist in co-ordinating and be involved in the execution of all stages of the validation life cycle including:

* Assisting with development of project design documentation.

* Generating validation plans for larger projects.

* Risk assessing validation requirements.

* Liaison with non-Pharma Services personnel (including manufacturers, suppliers, external validation resources, clients)

* Preparation of validation protocols and reports

* Collation and analysis of process validation data

* Performing and witnessing validation activities

2. Assist in the monitoring and periodic revaluation of processes and systems

3. Regularly update the schedule of current validation projects

4. Liaise with key personnel within project teams to ensure validation tasks are planned, monitored and completed in a timely manner

5. Assist in the execution of testing to meet operational requirements

6. Liaise with Quality Control/Analytical to ensure that all relevant validation testing is performed and reported.

7. Liaise with Quality Assurance to ensure GMP is adhered to in all areas of validation testing and that systems are fully validated and all documentation completed before they are released for use.

8. Keep abreast of the regulatory environment surrounding qualification and validation.

9. Act as a Subject Matter Expert (SME) as applicable, in support of planned and unplanned changes.

10. Provide review and approval on a range of technical documents including Standard Operating Procedures (SOPs'), Master Batch Records (MBRs') and Technical Protocols and Reports etc.

11. Participate in local and global business projects as and when required.

Required Skills & Experience:

- Experience working within a Pharmaceutical Manufacturing environment

- Experience working with Quality Systems

- Experience working within a regulated environment