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mRNA - Specialist, Validation - Vaccine (m/f/d)


About you:

  • Bachelor's (or post-graduate degree) in a relevant field to the biotech or pharmaceutical industry.
  • Must have 3+ years of experience within a Validation organization in the pharmaceutical, biologics or medical device industries.
  • Must have 3+ years of experience in working with facility start ups, factory/site acceptance testing, Commissioning/Qualification activities and all associated supporting documentation generated during the course of these activities.
  • Experience with continuous improvement of Validation operations in response to business needs and customer audits/regulatory inspections.
  • Experience in execution of field activities associated with validation protocols, project plans, data analysis, compilation of data into final reports and project summary / close out.
  • Experience in asset management and in NIST traceability to standards.
  • Demonstrated experience in working in compliance with US, EU and ICH GMP requirements.
  • Preferable experience in early phase clinical efforts, which are not under the stringent requirements of a commercial facility.
  • Preferable experience in supporting a Phase I/II company up through commercialization.
  • Excellent oral and written communication skills.
  • Strong interpersonal skills to effectively manage teams, communicate with peers, management and external contacts.

Key responsibilities for position:

Support Sanofi's mRNA CoE Validation department
  • Field support of the FTE and consultant activities in the Commissioning, Validation and Maintenance phases of the Validation Lifecycle of the relevant Facilities, Utilities, Systems and Equipment.
  • Author the necessary Validation Protocols and Project Plans, and support all field activities performed in support of their execution.
  • Help drive on time deliverables in a compliant manner, while serving as the Validation Subject Matter Expert and interacting with customers on their needs.
  • Serve as liaison and cross-functional lead with Engineering, Manufacturing and Quality Assurance to provide an overall compliant program with industry standards and GMP regulations.
  • Help review proposed changes to validated systems and identify the validation requirements necessary to maintain the system's validation status after execution of the change.
  • Help enforce compliance to senior leadership strategy and direction, as it pertains to the areas of cleaning validation, equipment validation, computer systems validation and routine maintenance of validated systems.
  • Support the phase appropriate strategy to the validation deliverables for new and existing facilities and labs.
Support Sanofi's mRNA CoE Metrology department
  • Support the site-wide calibration and maintenance program for all Sanofi mRNA CoE owned GxP equipment and systems.
  • Support the planning, scheduling and completion of all Metrology work performed to ensure timely maintenance and calibration activities on
  • Sanofi's mRNA CoE owned equipment and systems.
  • Help investigate and support management in all investigations stemming from instrument failure and determines best course of action for resolution
Promote a Quality Culture
  • Support innovation, teamwork and a continuous improvement effort in the level of Quality in Sanofi's mRNA CoE documentation.
  • Ensure that Sanofi's mRNA CoE Validation documentation meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.

» Job description

Waltham, MA [USA]