Process Engineer Job at Randstad USA, Saint Louis, MO

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  • Randstad USA
  • Saint Louis, MO

Job Description

Description:

KEY RESPONSIBILITIES

The successful candidate will work with a group of scientists and engineers responsible for support of commercial mammalian cell culture processes in the external manufacturing MSAT group. This group supports commercial operations across a diverse network of manufacturing facilities and external partners.

Key responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

• Provide technical support and routine process monitoring for commercial products manufactured at CMOs.

• Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.

• Reviews manufacturing processes, deviations, and/or development and production data.

• Reviews manufacturing batch records, protocols, and control strategies.

• Provide technical support and data analysis for investigations and deviation resolution.

• Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.

• Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments.

• Oversees and reports on overall manufacturing progress.

BASIC QUALIFICATIONS

• Bachelor’s degree in engineering or science with 5 years of experience

OR

• Master’s degree in engineering or science with 3 years of experience

• Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations

PREFERRED QUALIFICATIONS

• Experience with Good Manufacturing Practices and supporting a commercial facility

• Experience in cell culture and/or downstream purification (direct lab experience a plus)

• Experience with equipment qualification and process validation

• Familiarity with formal root cause analysis and/or risk assessment

• Experience working with statistical analysis software and investigative data analysis

• Experience with project leadership

• Experience communicating with cross functional teams

• Strong technical writing and communication skills

• Proficient in Microsoft Word, Excel, and PowerPoint

SPECIAL WORKING CONDITIONS

• Ability to gown and gain entry to manufacturing areas

• Ability to travel (up to 20% of time)

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