harbaheadercoverblack.png

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.

Qualifications:

  • 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.
Share this job:

Apply now

Similar Jobs

Manufacturing Associate

Cambridge 24 - 30 p/h Permanent

Job Responsibilities: Execute manufacturing procedures in an ISO Class 7 clean room, adhering to SOPs, cGMPs, and safety regulations. Perform...

Formulation Chemist

Indianapolis 70K - 105K Permanent

Key Responsibilities: Designing and executing synthetic routes for the preparation of target molecules, including s...

Histotechnologist

Boston $80,000 - $90,000 Permanent

Job Responsibilities: Process human tissue and body fluid specimens in preparation for microscopic exam Perform technical duties related to th...

Validation Engineer

Cambridge 85K - 100K Permanent

Job Responsibilities: Develop and publish new validation project plans and protocols, execute protocols, and write final reports with minimal su...

Industrial Engineer

Fishers 60 - 80 p/h Permanent

Job Responsibilities: Analyze and evaluate manufacturing processes to identify areas for improvement in terms of efficiency, cost, and quality...