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.

Job Type:

Full-time Pay:

$35.00 - $40.00 per hour

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Relocation assistance Vision insurance

Work Location:

In person