My client, a leading UK biopharma are looking qualification engineers for a number of CAPEX projects.
Title: Qualification Engineer
Salary: £50- 60 p/h
Location: North East
• Support quality aspects of qualification and validation of equipment, facilities, and utilities associated with manufacturing/warehousing to ensure compliance with company policies, procedures and regulatory expectations.
• Develop and execute protocols for the execution of commissioning and qualification activities. (DQ, FATs, SATs, Installation Verification, Functional Testing, IQ and OQ)
• Will serve as the Quality SME for validation activities on the project including but not limited to: Utility and equipment performance qualification & Cleaning Validation.
• Provide Quality oversight for any temperature mapping studies, for example, standalone TCU’s, Warehouse temperature controlled storage, Site Stability rooms.
• Input to Standard Operating Procedures (SOPs)
• Serve as a quality resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.
• Work closely with stakeholders and SME’s from site operations, quality operations, engineering to provide quality oversight throughout the qualification and validation lifecycle.
• Use of Quality Risk Management and Operational Excellence to promote continuous improvement. Qualifications and Experience
• This role requires a minimum of 8 year’s experience in Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
Must have at least 5 years of experience in commissioning, qualification, and validation activities in in a regulated environment.
• Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11
• Technical knowledge of validation/verification, quality systems and regulatory requirements
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If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to or call 0203 589 9282 for a confidential discussion about potential opportunities.
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