Cleaning Validation Specialist

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2021-08-12 11:12:161970-01-01Team Horizon
Job TypeRemoteContractor
SectorEngineeringQualityOperations & Manufacturing
Start Date
AdvertiserAshling Guthrie
Job Ref#2147
Job Views494
An exciting opportunity has arisen for an experienced Cleaning Validation Specialist for our Clients commercial and clinical Biologics and fill finish manufacturing plant. In this role, you will be responsible for performing cleaning and filter validation as well as supporting the technical services department in Technical Transfers. This role will be a mix of both onsite and remote work.
Why you should apply:
  • This is an opportunity to join a fast moving, rapidly growing entrepreneurial organisation that pursues its mission to transform patients' lives with persistence, dedication and perseverance. We are driven because we know their lives depend on it.
  • If you are Patient focused, like to challenge conventional thinking and enjoy collaborating to solve complex problems – then this is the company for you.
What you will be doing:
  • Execute cleaning validation/verification activities to ensure cGMP requirements are met
  • Manage and execute the multiproduct cleaning validation approach for new product introductions
  • Deliver specific cleaning and process validation projects according to business priorities and regulatory requirements
  • Review and approve process validation documentation to ensure it meets internal and regulatory requirements
  • Develop process validation plans, protocols and reports and co-ordinate and manage their execution
  • Oversee all responsibilities and perform additional tasks assigned by the departmental manager
  • Carry out all duties in accordance with Development and Production Safety and Quality policies
  • Participate and contribute in the design and development of automation, equipment and process/cleaning validation strategy
  • Provide technical input to strategy/philosophy for validation of equipment and automation changes associated with cleaning processes
  • Execute and manage Filter Validation on site
  • Responsible for developing and executing commissioning and qualification documentation for new or modified process systems and equipment. This may include the development of user and function requirements, execution of factory/site acceptance testing, commissioning, and development of design qualifications
  • Support the execution of validation studies specific to filter validation, process simulations and process validation.
  • Support and execution the requalification program.
  • Support department to be audit/inspection ready and participate in audits and regulatory inspections as required.
  • Serves as one of the Company point of contact for cleaning validation studies performed by external contractors or vendors, coordinating execution of studies with Company’s Manufacturing Operations, Engineering, Utilities and QA personnel as required.
  • Support continuous improvement of Company facilities and equipment by risk assessing proposed changes to ensure the qualified state is maintained. Generate and execute approved change control test scripts to demonstrate that proposed changes are appropriate and do not impact cleaning and process validation.
  • Proactively take action to consistently improve personal knowledge and capability. Demonstrate an awareness of own capabilities and development needs. Demonstrate a proactive approach to gaining new knowledge, skills and attributes.
  • May be required to perform other duties as assigned.
What you need to apply:
  • Bachelor’s Degree in engineering or scientific discipline preferred.  Associate’s degree or certificate in biotechnology (minimum) required.
  • Direct experience performing validation studies in cGMP biopharmaceutical or aseptic filling/Biologics environment is required.
  • Cleaning validation and filter validation experience
  • Knowledge of Biologics, aseptic processing and liquid filling operations preferred.
  • Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.  Must be able to function effectively in a teamwork environment.
  • The individual in this position is expected to represent Company Pharmaceutical interests, objectives and policies in a professional and responsible manner.
  • Five years’ experience in a cGMP biopharmaceutical or Biologics/aseptic filling environment is preferred but not required.
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