Filling and Capping Operator

TheFilling &Capping Operator (Operator II& III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, operatingfill lineequipment, conducting inspections of filled units, batch count reconciliation,compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of componentsand terminal sterilization in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards.The Operator will alsoinitiateminor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator maybe requiredto cross-train as a support Operator foradditionalareas. This position reports to the Manufacturing Supervisor.

EssentialDutiesandResponsibilities(theseareprimaryresponsibilitiesoftheroleandtheincumbent will perform other duties as assigned):

Understand and follow current Good Manufacturing Practices(GMP)

Understand and follow current GoodDocumentationPractices(GDP)

Perform routine cleanup, line clearances,and sanitizations as assigned by area supervision tomaintaincGMP compliance within theCleanroomwork areas.Perform sanitizations ina timelyand effective mannerin accordance withcGMPsandSimtraprocedures,maintainingproduction schedule.

May berequiredto cross train as a support operator toassistadditionalmanufacturing areas.

Maintain organization at all timeswithin the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.

Perform routine verification of equipmentand instruments.

Setup andoperateaseptic filling equipment for routine aseptic processes, performed with proper aseptictechniqueto prevent negative safety, identity, strength,purityand quality impact to the batch.

Perform routine operationsutilizingaseptic formulation and filling equipment inCleanroomareas.

Perform environmentalmonitoring;including fingertip, contact, and fallout plates.

Assistin the training and development of other team members

Required tomaintainattendancein accordance withthe Bloomington Attendance Policy

Scheduled weekend overtimemayberequired

Successfuloperatorqualification/mediafillperformancerequiredto achieve increased operator levels

JobRequirements(Education,ExperienceandQualifications):

High school diploma or GEDrequired, 6 months ofpreviousPharmaceutical or Manufacturing experience preferred.

Must be able to understand, speak,readand write Englishin order tocomply withnecessary SOP's, job-specific training materials, GMP's, and other manuals.

Basic Computer skillsinMicrosoftWord,Excel,andOutlookandtheabilitytouseenterprisesoftware(examples include:Veeva, D365, Blue Mountain, etc.)

Musthavetheabilitytoworkeffectivelyina"handsonenvironment"capableoftroubleshootingcomplex equipmentandsystems

Competency inoperation 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.Ability todemonstrateproficiencyin reading equipment drawings.Ability to work safely with equipment under pressure.

Physical/SafetyRequirements

Mustbe abletoliftand carryupto50lbs, andpush and pullup to 50 lbs.

Extendedperiodsofstandingand/orwalking

ExtendedperiodsinGradeA,B,C,Dproductionenvironments

Useofhandsandfingerstomanipulateequipmentisrequired

In return, you'll be eligible for[1]:

Day One Benefits

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

Supplemental Life Insurance

Spouse Life Insurance

Child Life Insurance

401(k) Retirement Savings Plan with Company Match

Time Off Program

Paid Holidays

Paid Time Off

Paid Parental Leave and more

Adoption Reimbursement Program

Education Assistance Program

Employee Assistance Program

Community and Volunteer Service Program

Employee Ownership Plan

Additional Benefits

Short and Long-Term Disability Insurance

Voluntary Insurance Benefits

Vision Coverage

Accident

Critical Illness

Hospital Indemnity Insurance

Identity Theft Protection

Legal and more

Onsite Campus Amenities

Workout Facility

Cafeteria

Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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