Laboratories Lead
Heredia, Costa Rica
hace 5 días


  • Responsible to develop, transfer and implement testing processes of starting materials, device components, packaging materials and drug products according to approved and validated test methods.
  • Responsible to develop, transfer and implement testing of environmental monitoring samples, bioburden, monitoring and analysis (water, compressed air), endotoxins tests, among others as needed.
  • Responsible for the reliability of the analyses and results.
  • Responsible to define, acquire and validate the laboratory equipment as well as ensuring maintenance and calibration activities.
  • Lead development and validation of test methods and transfer of test methods. Ensure readiness for Operations based on project timeline.
  • Responsible to lead sterilization validation processes, qualify suppliers to perform related sterilization quality tests and perform sterilization requalification activities as required.
  • Provide design guidance and support of the laboratory’s areas.
  • Responsible to create Quality Master Data for QM Module in SAP.
  • Responsible for delivering Bayer B certificates along the project delivery roadmap in required quality and aligned timeline corresponding to Laboratories.
  • Write, review and / or approve qualification protocols and reports in collaboration with other team members.
  • Responsible to establish and monitor the budget of the laboratories according the project need. Take necessary actions, if required.
  • Responsible to implement short term, mid-term and long term capacity planning.
  • Responsible to hire, train, guide and lead chemists, lab technicians, technical assistants (laboratory work).
  • Provide appropriate initial and continuing training for the laboratory personnel.
  • Team member to track progress and escalate to Quality lead, if needed.
  • Performs other duties and tasks as required to support the project development, leading to and through operational start-up and sustainable commercial operation.

  • BA / BS required in (Chemical Engineering, Chemistry, Microbiologist, Biotechnologist).
  • 5 years of experience in microbiological laboratories.
  • 2 years of leadership experience.
  • Advanced English level, both written and spoken.
  • Experience on chemical and physical labs is a plus.
  • Knowledge in sterilization process and validation.
  • Statistical Techniques Knowledge.
  • Knowledge of QMS systems and subsystems utilized to manage and regulate work and workflow within pharma or medical device industry.
  • Process Validation Knowledge.
  • Knowledge of laboratory systems / systems management.
  • Knowledge on analytical method validation process.
  • Knowledge in technology transfer.
  • Proficient with Microsoft Office tools.
  • Demonstrated advanced problem-solving abilities.
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