Filling Operator, 1st Shift

About the position

The Filling Operator (Operator III) position is responsible for aseptic execution of assigned activities within the Grade A/B manufacturing area; activities shall include current Good Manufacturing Practices (cGMP) compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and fill machine equipment, and conformance to Good Documentation Practices (GDP) standards. A Filling Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. This Filling Operator may be required to cross-train as a support Operator for additional areas. This position reports to a Manufacturing Supervisor. Shift: Monday- Friday, 7:00am - 3:30pm.

Responsibilities

• Understand and follow current Good Manufacturing Practices
• Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade A/B work areas.
• May be required to cross train as a support operator to assist additional manufacturing areas.
• Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.
• Perform routine verification of equipment when unloading autoclaves and setting up aseptic filling machines.
• Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality (SISPQ) impact to the batch.
• Perform routine operations utilizing aseptic formulation and filling equipment in Grade A/B areas.
• Perform environmental monitoring; including fingertip, contact, and fallout plates.
• Assist in the training and development of other team members.
• Required to maintain attendance in accordance with the Bloomington Attendance Policy.
• Scheduled weekend overtime will be required.

Requirements

• High School diploma or GED required.
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Ability to work independently.
• Good communication skills.
• Good documentation skills, including legible handwriting.
• Good interpersonal skills.
• Basic computer skills.
• Basic math skills.
• Knowledge of aseptic manufacturing practices.
• Knowledge of standard operating procedures, specifications, and job-specific training materials.
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices.

Benefits

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Voluntary Insurance Benefits
• Vision Coverage
• Accident Insurance
• Critical Illness Insurance
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal Assistance