Production Engineering Specialist

5 days ago


Frederick, Maryland, United States Fladger Assoc. Inc. Full time

We are seeking an experienced Production Engineering Specialist to join our team at Fladger Assoc. Inc. in Frederick, MD. As a key member of our production team, you will be responsible for conducting or participating in technically fast-paced projects within a specific area or field.

Job Description

This role requires strong problem-solving skills, adaptability, and the ability to work collaboratively and efficiently. You will support the design of validation sampling/test plans and perform development studies, ensuring accuracy and attention to detail.

Responsibilities:
  • Develop and implement efficient methods for preparing media and buffers to support MST experiments.
  • Collaborate with cross-functional teams to monitor and maintain lab equipment and inventory, promoting efficiency and organization.
  • Analyze data and prepare reports to support scientific studies, resolving technical issues and ensuring quality results.
  • Support technology transfer activities, including method validation/method transfer, filter validation, shipping qualification, and FAT/SAT/Commissioning activities.

Requirements:

  • Bachelor's Degree in Science or Engineering, preferably with Biology education.
  • At least three (3) years of experience in Scientific/Biotech/Pharmaceutical field, with expertise in Biologics working in cell culture and purification of large molecules in therapeutic antibodies, vaccines, or injectables.
  • Knowledge of GMP manufacturing principles and documentation, ensuring compliance and adherence to industry standards.
  • Ability to apply critical thinking to solve problems and work independently, with strong interpersonal and communication skills.

Estimated salary range: $115,000 - $140,000 per year.



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