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Cleaning Validation- BIO

  1. NI & Ireland
  1. Contract
Competitive
24576 JL
  1. Commisions, Qualification and Validation
Date Posted13 Mar 2020
Cleaning  Validation Specialist  required for a world Leading bio tech organization who are at a Peak phase in establishing an innovative and industry leading manufacturing facility in Dublin Ireland.
 Working in their state of the art  manufacturing suites, the  Cleaning Validation Engineer will be responsible for   implementing Cleaning Strategies across varied process equipment
 Key Duties are as follows:
Cleaning Validation Technical Specialist will support the cleaning verification/validation activities for the cGMP manufacture of biological bulk drug substance
  • The Specialist will support cleaning verification/validation readiness and execution to support the facility commissioning, start-up and routine commercial manufacturing. 
  • The Cleaning Validation Technical Specialist will be responsible for validation and verification of the cleaning used to support the technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with Operations, Engineering, Quality Assurance, Quality Control, Regulatory and other involved departments to ensure successful facility start up and qualification.
  • The position is accountable for timely completion of cleaning validation/verification related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility.
 


Principal Responsibilities
  • Implement cleaning strategies for fixed and mobile parts per Cleaning Validation Master Plan and associated strategies.
  • 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 where applicable.
  • Generate and execute cleaning validation protocols, plans and reports as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable and representative cleaning sampling activities.
  • Work closely with colleagues within the Technical Services team, and with Quality Assurance, Quality Control, Commissioning, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of startup, technology transfer, and routine manufacturing timelines in the context of cleaning validation.
  • May author and review cleaning risk assessments, technical protocols and reports, cleaning validation documents, cleaning sample maps 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).
  • Partake in Tier Management meetings to ensure alignment between Operations and QC for sample co-ordination.
  • Identify and implement improvements where feasible.
  • Provide oversight in the execution of cleaning trials and studies on the manufacturing floor at commercial scale relating to media/buffer preparation, and process equipment.  Temporary shift working may be required during periods of engineering batch and validation batch execution.
  • Provide on the floor support for troubleshooting cleaning verification/validation related issues and to lead/partner on cleaning/manufacturing investigations into process deviations.
  • Author/review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities.
  • Collate cleaning verification/validation data in control charts and identify any trends.
  • May serve as a subject-matter expert on specific cleaning verification/validation activities during regulatory agency inspections.
  • Ensure samples are taken when required and accounted for per plan. Ability to escalate issues or learnings in a timely manner to ensure no impact to cleaning validation workfront.
 


Qualifications
  • Experience in Cleaning verification/validation / Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance or drug product manufacturing organization.
  • Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities (would be advantageous).
  • Experience of cleaning verification/validation is beneficial, 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 organization.
  • Ability to present and successfully defend technical and scientific approaches in both written and verbal form.
  • Ability to drive for results independently and adapt to rapidly changing priorities
 


Education
  • Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.

 Please apply now with you CV to be considered for this long-term opportunity. 

 





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