We are currently looking for a Cleaning Validation Specialist to join a leading Pharmaceutical Contract Development Manufacturing Organisation based in the West Yorkshire area. As the Cleaning Validation Specialist you will be responsible for ensuring validation studies and activities are planned and executed in line with defined external and internal standards. You will be the on site specialist in all cleaning validation activities.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Cleaning Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. Liaise with Manufacturing, Engineering, Quality Assurance and User Departments to ensure that validation is tracked and completed in accordance with the Site Validation Master Plan.
2. Define the Cleaning Validation program in line with regulatory expectations using a risk based matrix approach. Manage cleaning validation activities in line with the predefined plan. Execute Warehouse temperature mapping qualification and re-qualification activities across the site.
3. Ensure the timely creation, approval and execution of qualification and validation protocols as required to meet the business needs, including the on-site purified water system. Plans and protocols are well-defined and appropriate testing standards and acceptance criteria are clearly specified.
4. Work as part of a multi-functional team in conducting risk assessments to identify qualification and validation requirements for new products and changes to product, processes and equipment.
To be successful in your application to this exciting opportunity as the Cleaning Validation Specialist we are looking to identify the following on your profile and past history:
1. As the Cleaning Validation Specialist you will be degree qualified in either a Scientific or Engineering discipline.
2. Proven industry experience as a Cleaning Validation Specialist within a highly regulated cGMP manufacturing environment, such as the Pharmaceutical, Biotechnology or Medical Device industry.
3. A working knowledge and practical experience with cleaning validation, temperature mapping and purified water systems.
Key Words: Cleaning Validation | Pharmaceutical | CDMO | GMP | Manufacturing | Validation | Temperature Mapping
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.