Aseptic Manufacturing Specialist

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.