Clinical Manufacturing Operator

Job Description

Simtra BioPharma Solutions is seeking a Clinical Manufacturing Operator to join their team in Bloomington, Indiana. This role is responsible for executing tasks related to the production of drug products in the Clinical manufacturing area. The Clinical Manufacturing Operator reports to the Operations Specialist – Clinical Manufacturing.

The role involves:

• Aseptic filling line setup and operation
• Formulation of drug products
• Lyophilizer use
• Cleaning/sanitization of area and equipment
• Adhering to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) standards

Requirements:

• High school diploma or GED required
• 2 years of experience operating and troubleshooting complex production equipment preferred
• 1 year pharmaceutical manufacturing related experience preferred
• Knowledge of cGMP manufacturing preferred
• Knowledge of basic laboratory and pharmaceutical production equipment preferred
• Prior work in clean room environments (ISO 5/7/8, Grade A/B/C/D) preferred
• Computer proficiency in Microsoft Word, Excel, and Outlook
• Ability to stand for extended periods of time
• Ability to lift up to 50 pounds
• Must be able to understand, speak, read and write English

Simtra BioPharma Solutions offers:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Paid Time Off
• Paid Holidays
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Onsite Campus Amenities including a Workout Facility, Cafeteria and Credit Union