Process Validation Specialist

Full Time
Job Sector:
Engineering / Technical
Swindon / Wiltshire
Salary description:
Start Date:
Hyper Recruitment Solutions LTD
Job Ref:

Are you an experienced Process Validation Engineer / Specialist looking for a new exciting job opportunity?
We are currently looking for a Process Validation Specialist to join a leading biopharmaceutical company based in the Wiltshire area.
As the Process Validation Specialist you will be responsible for the coordination and timely completion of Process Validation studies in support of manufacturing activities and regulatory requirements. The role will include the writing, review and execution of process validation plans, protocols and reports and the coordination of support activities to deliver on time a high standard of documentation.
Your duties as the Process Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for the coordination and execution of the Validation Master Plan with respect to Process Validation activities. You will also assess change control documentation to determine change impact with respect to the validation requirements and report appropriately.
2. As the process validation specialist, you will also support operational areas in the implementation of change, support process validation activities, define the process validation strategies and schedule process validation executions.
3. You will also present Process Validation documents at regulatory audits, perform process investigations with relevant departments as required, perform product and process impact assessments as well as participate in or lead process and quality risk assessments.
4. Additionally, you will maintain and review the Product Control Strategy for all products, understand the
functional relationships that link CMA/CPP to CQA and ensure the timely completion of Deviations and the closure of CAPAs.
To be successful in your application to this exciting opportunity as the Process Validation Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a pharmaceutical, engineering or life sciences field.
2. Proven industry experience of process validation ideally within a pharma or biopharmaceutical environment. You will also need to have a good understanding of the validation life cycle and project management experience.
3. Biotechnology experience and statistical evaluation of data experience would be desirable.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves

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