Process Engineer II

at  Thermo Fisher Scientific

St. Louis, MO 63134, USA -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate01 Dec, 2024Not Specified05 Sep, 20242 year(s) or aboveProcess Analysis,Microsoft Word,Excel,GmpNoNo
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Description:

EDUCATION

  • Bachelor’s degree required in a scientific field, preferably an engineering field with 2+ years experience.
  • Master’s degree in a scientific field, preferably an engineering field.

EXPERIENCE

  • 2+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience.
  • Follow Environmental, Health and Safety policies and procedures and ensure a safe and balanced workplace environment.
  • Ability to self-motivate, prioritize work and time.
  • Demonstrates a foundation in general scientific practices, principles, and concepts.
  • Writes and communicates efficiently.
  • Ability to work both independently and as part of a team.
  • Knowledge of current Good Manufacturing Practices and US/EU regulations.
  • Novice knowledge of statistical methods used for Pharmaceutical Process Analysis is a plus.
  • Proficient in Microsoft Word and Excel.
  • Ability to stand for prolonged periods of time and gown into manufacturing areas.

Responsibilities:

  • Draft Standard Operation Procedures, and Job Aids.
  • Collaborate with the process development to assess standardized methodologies and learn new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.
  • Support Internal and Customer meetings based upon sound evidence guided by supervision.
  • Manage internal projects and tasks and assists in leading client projects and managing timelines with support from supervision.
  • Actively identify error proofing opportunities and drive engineering initiatives to improve practices and procedures with supervision.
  • Provide scientific expertise for GMP deviations by assessing the impact of major deviations on both the product quality and the validation of the process.
  • Lead changes to equipment and process design.
  • Draft, review and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing.
  • Draft Process control documents, campaign summary report and process validation reports
  • Reviews, analyzes and trends process data with minimal direction
  • Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
  • Solve technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility.
  • Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers.
  • Provides development and training for Process Engineers/Scientists.


REQUIREMENT SUMMARY

Min:2.0Max:7.0 year(s)

Pharmaceuticals

Engineering Design / R&D

Clinical Pharmacy

Graduate

A scientific field preferably an engineering field with 2 years experience

Proficient

1

St. Louis, MO 63134, USA