Validation Engineer (Biopharmaceutical)
We have two exciting opportunities for two experienced Validation Specialists to join a Biopharmaceutical company near Oxfordshire area has become available.
Each role as the Validation Specialist, will be responsible for being the subject matter expert for new filling equipment being brought into the new facility. You will be hands on, yet operate at a senior level with experience working with Isolators and Vaporised Hydrogen Peroxide (VHP) systems.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. You will support either the Process Validation for biological products, or the Equipment Qualification of the Isolators and new filling equipment. This will include liaising with internal functions including Engineering, Manufacturing, QC, QA and Manufacturing Development.
2. You will prepare and maintain validation plans (VPs), assisting system owners with impact assessments and identifying validation requirements.
3. As the Validation Specialist you will effectively manage/close-out any deviations, and represent the Validation Department during client audits and regulatory inspections.
4. You will lead validation related activities for the new facility. This may include design, qualification and continued process verification of the organisation's manufacturing processes, including identification of opportunities for improvement.
To be successful in your application to this exciting opportunity as the Validation Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Science or Engineering related discipline or a broad knowledge of biopharmaceutical and pharmaceutical industry regulations and guidelines including GMP, GDP, GLP, GEP.
2. Proven industry experience as a Validation Engineer or Validation Specialist within a Biopharmaceutical, sterile GMP environment. You will have worked with Isolators and related filling equipment, or with Vaporised Hydrogen Peroxide (VHP).
3. A working knowledge and practical experience with Eudralex Volume 4, annex 11 & FDA 21CFR Part 11.
Key Words: Process | Equipment | Validation | Manufacturing | Biopharmaceutical | Pharmaceutical | IQ | OQ | PQ | URS | Annex 11 | GDP | GMP | GLP |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals and scientists. We look forward to helping you with your next career moves.
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