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Aseptic Manufacturing Specialist

Indianapolis $26.00 - $32.00 p/h Permanent

Responsibilities

  • Follow production and manufacturing procedures.
  • Perform duties in Grade C, D, and controlled non-classified cleanrooms.
  • Conduct aseptic manipulations within Grade A isolators.
  • Perform cleaning, sanitization, equipment preparation, and aseptic filling as needed.
  • Operate production equipment safely, including setup and changeovers.
  • Accurately document data and complete batch records.
  • Execute validation and engineering protocols.
  • Train others in manufacturing tasks such as fill/finish, sanitization, and equipment preparation.
  • Maintain production equipment and troubleshoot operational issues.
  • Support equipment optimization and continuous improvement efforts.
  • Collaborate with cross-functional teams to ensure efficient operations.
  • Work flexible hours to maintain production coverage.

Qualifications

  • High school diploma (or equivalent) and a minimum of 3 years of GMP pharmaceutical experience with aseptic filling equipment.
  • Working knowledge of Microsoft Office (Word, Excel, Windows).
  • Understanding of pharmaceutical or biotechnology manufacturing, aseptic processing, and cGMP standards.
  • Bachelor’s degree in biological sciences, biotechnology, or related field preferred.
  • At least 1 year of GMP pharmaceutical experience involving installation, operation, cleaning, and maintenance of production equipment preferred.
  • Experience performing aseptic manipulations within a Grade A isolator preferred.
  • Strong communication and interpersonal skills.
  • Ability to apply basic mathematical concepts such as fractions, percentages, ratios, and proportions.
  • Ability to learn and operate industry systems, including ERP and inventory management software.
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