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PDS Tech Inc Sr. Process Engineer in Saint Louis, Missouri

Job Description:

The Sr. Process Engineer will lead process engineering, operational excellence and capital projects related to the manufacturing of active pharmaceutical ingredients, with a focus on Cell Culture. The role will require the Sr. Process Engineer to lead projects independently, or as the leader of a cross-functional team. There will be extensive involvement in Engineering from conception through design; during equipment specification, startup, and validation as necessary for the projects. This position will lead, execute and coordinate the project activities of the internal project team and any other necessary resources, including but not limited to; outsourced engineers and designers.

Education:

  • Bachelor of Science degree in Engineering required.

  • Chemical, Electrical or Mechanical Engineering preferred.

  • Civil, Industrial or other Engineering field acceptable with relevant work experience.

  • Formal Project Management training and certification such as PMP, is preferred.

Experience:

  • 7+ years of Process Engineering/Project Management experience in the pharmaceutical manufacturing (or similar) industry.

  • Solid knowledge of global current Good Manufacturing Practices (cGMP) in active pharmaceutical ingredients and/or finished pharmaceutical manufacturing.

  • Validation experience in a pharmaceutical environment is desired.

  • Must possess a high level of proficiency in a technical core competency.

  • Active participation in industry organizations such as ISPE is a plus.

  • Excellent verbal and written communications skills with the ability to build and drive cross-functional teams.

  • Strong customer focus and drive for results with strong problem-solving abilities.

  • Capable of setting clear priorities, organizing work, and making quality decisions in a fast-paced business setting.

  • Proficient with Microsoft Project.

  • Experience in managing complex engineering projects through cross-functional teams.

  • Knowledge and experience in a regulated environment to ensure regulatory compliance is achieved. GMP experience is preferred.

  • Familiar with upstream and downstream bioprocess operations and equipment.

  • Define process requirements and establish project design criteria based on engineering analysis and evaluation. Prepare detailed functional specifications.

  • Experience in critical engineering tasks; forecasting, specifications, design guidelines, etc.

  • Experience, training and certification in Operational Excellence (Six Sigma, Lean) is preferred.

  • Responsible for the overall management and execution of assigned projects to meet the goals of scope, cost and schedule.

  • Ability to analyze and review processes, process development work, and economic studies as required to develop the project alternatives and final developed scope.

Physical:

  • 5% - 15% Travel may be required.

  • Risk of exposure to chemicals in a plant environment.

  • Work around biopharmaceuticals, chemicals, plant utilities equipment and at construction sites.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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