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Cleaning Validation Specialist

Reference ID : 0493MQ
Category :
  • Pharma / Biotech
Date Posted : Sep 25, 2018
Job Location
:
  • Leinster
- Dublin
Experience : Minimum 5 years
Salary : Negotiable - DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 086-0435195
Headcount Engineering is seeking a Cleaning Validation Specialist for our pharmaceutical client in Dublin.

Principal Responsibilities

  • Develop, author, and maintain the Cleaning/Validation Master Plan to support the start-up of a multi-product drug substance manufacturing facility.
  • Develop and implement cleaning strategies for fixed and mobile parts.
  • Development and/or optimize cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
  • 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.
  • Work closely with colleagues within the Technical Services team, and with Quality, Commissioning, Manufacturing Operation, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of start-up, technology transfer, and routine manufacturing timelines in the context of cleaning validation.
  • Author and review process transfer documentation, cleaning risk assessments, technical protocols and reports, cleaning validation documents and supporting documentation as required.
  • Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained.
  • Identify requirements for process, plant, or laboratory studies/trials to support cleaning verification/validation activities and to liaise closely with Operations/QC to oversee the design and execution of studies (as required).
  • Identify and implement improvements where feasible.
  • Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale relating to media/buffer preparation. 
  • 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.

Qualifications & Requirements

  • B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
  • Minimum 5 years’ experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organization 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.
  • Ability to present and successfully defend technical and scientific approaches in both written and verbal form.

For further information, please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie



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