Manufacturing Specialist II

Lexington $33 - $37 p/h Permanent

Job Responsibilities:

  • Practice and promote safe work habits, adhering to all safety procedures and guidelines.
  • Utilize manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues, improve operations, and drive positive change.
  • Perform root cause analysis on manufacturing quality events and lead investigations for both minor and major quality issues.
  • Identify and drive corrective and preventative actions in the manufacturing process.
  • Provide support for technology transfers within manufacturing.
  • Participate in cross-functional teams to drive complex manufacturing operations changes or improvements.
  • Support document revisions and management, including batch production records and manufacturing procedures.
  • Provide expertise in processing technologies (chromatography, filtration, digital systems, etc.).
  • Perform work requiring independent decision-making and judgment, with periodic management guidance.
  • Review the work of others and provide constructive feedback.


  • BS or MS degree in Biology, Biochemistry, Molecular Biology, or a related field, or equivalent experience.
  • Experience owning, investigating, and writing deviations, creating and executing CAPAs, and managing Change Controls.
  • Experience in biomanufacturing unit operations (USP and/or DSP).
  • Experience performing root cause analysis using methods such as Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, and basic Quality Improvement Tools.
  • Minimum 2-3 years of industry experience in a related field.
  • Hands-on experience in writing and reviewing documentation.
  • Ability to apply systems thinking in problem-solving.
  • Demonstrates industrial empathy when working with stakeholders.
  • Detail-oriented and capable of self-organization.
  • Professional communication skills across diverse levels and channels.
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