Aseptic Equipment Specialist

Job Responsibilities:

• Follow established production and manufacturing procedures in a compliant manner.
• Perform duties within Grade C, D, and controlled non-classified cleanrooms.
• Conduct aseptic manipulations within Grade A isolators.
• Safely operate production equipment, including setup and changeovers.
• Lead batch start-up activities, oversee production cycle execution, and implement validation/engineering protocols as required.
• Train team members on various manufacturing processes, including but not limited to fill/finish, sanitization, and component/equipment preparation.
• Contribute to equipment optimization and continuous improvement efforts.
• Proactively address and resolve operational challenges with timely solutions.
• Support and participate in process FMEAs to assess and mitigate process and product risks prior to validation.

Qualifications:

• High School diploma with 7 years of GMP pharmaceutical experience, including installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• OR a BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience, including installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• Proficient in MS Office (Word, Excel, Windows) or equivalent software.
• Demonstrated knowledge of pharmaceutical manufacturing, including biotechnology products, aseptic processing (fill and finish), and cGMP.
• Excellent communication and interpersonal skills.
• Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Capacity to learn and operate various industry systems, including ERP and inventory management systems.