Cleaning Validation Engineer

England  ‐ Onsite
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Description

Cleaning validation engineer required to join a global pharmaceutical company located in the South West UK for an initial 6 month contract.

Role and responsibilities:
  • Generate and execute cleaning validation protocols as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities.
  • Author and review process transfer documentation, cleaning risk assessments, technical protocols and reports, cleaning validation documents and supporting documentation as required.
  • Prioritise cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained.
  • Identify and implement improvements where feasible.
  • Provide on the floor support for troubleshooting cleaning related issues and to lead manufacturing investigations into process deviations.
  • Author and review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities.
  • Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections.
Skills:
  • Minimum 5 years' experience in a cleaning validation capacity.
  • Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities.
  • Experience of cleaning validation is a must, and/or cleaning approaches to multiproduct is advantageous.
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a Matrix organisation.
  • Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.

If this is you please apply today.
Start date
n.a
Duration
6 months initially
From
Quanta Consultancy Services
Published at
19.10.2017
Project ID:
1436826
Contract type
Freelance
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