Sign upSign in

Aseptic Manufacturing Specialist

Harba4 months ago
Indianapolis, IN, United States
On-site
Full-time
Junior Level (1-3 years)
Apply to Job

Job Description

Key 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.

Required 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.

Required Skills

Batch record documentation
Aseptic manipulations
Microsoft Office proficiency
GMP pharmaceutical experience
Validation and engineering protocols
Equipment setup and changeovers
Cross-functional collaboration
Grade A isolator operations
Cleaning and sanitization protocols
ERP and inventory management