Mitarbeiter Produkttransfer (m/w/d) at Eli Lilly and Company
berlion, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

05 Jan, 27

Salary

100000.0

Posted On

07 Oct, 26

Experience

18 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description


As Principal Scientist Validation, you will be expected to instruct and support the validation of production equipment and systems. Your responsibilities will include:


  • Sterilization validation, cleaning validation, filter validation, shipping validation, process validation, and other TS/MS related activity.
  • Prepare, review relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures.
  • Participate in development and implementation of process functional teams in positive fashion to implement TS/MS objectives and deliver on business and quality objectives.
  • Initiate related validation protocols and reports, and coordinate validation related activities Complete required and assigned trainings on-time.


Key Objectives/Deliverables


  • Instruct and support validation of production equipment and systems.
  • Prepare, review and support relevant technical documents.
  • Execute validation related activities.
  • Ensure compliance with the final objective and coordinate with local project team.
  • English fluent, additional German is preferred
  • The position is onsite, not hybrid, not remote


Requirements


Degree/qualifying certifications/training/experience: Engineer, pharmacist, or equivalent with professional experience (at least 5 years) in the industry. Knowledge of GMP Operation skills Good knowledge of document and project management. You have German and basic English knowledge. Additional

Responsibilities


As Principal Scientist Validation, you will be expected to instruct and support the validation of production equipment and systems. Your responsibilities will include:


  • Sterilization validation, cleaning validation, filter validation, shipping validation, process validation, and other TS/MS related activity.
  • Prepare, review relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures.
  • Participate in development and implementation of process functional teams in positive fashion to implement TS/MS objectives and deliver on business and quality objectives.
  • Initiate related validation protocols and reports, and coordinate validation related activities Complete required and assigned trainings on-time.


Key Objectives/Deliverables


  • Instruct and support validation of production equipment and systems.
  • Prepare, review and support relevant technical documents.
  • Execute validation related activities.
  • Ensure compliance with the final objective and coordinate with local project team.
  • English fluent, additional German is preferred
  • The position is onsite, not hybrid, not remote


Requirements


Degree/qualifying certifications/training/experience: Engineer, pharmacist, or equivalent with professional experience (at least 5 years) in the industry. Knowledge of GMP Operation skills Good knowledge of document and project management. You have German and basic English knowledge. Additional

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