Filling and Capping Operator
Simtra BioPharma Solutions, Bloomington, IN, United States
Filling And Capping Operator
Bloomington, Indiana, United States
The Filling & Capping Operator (Operator II & III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, operating fill line equipment, conducting inspections of filled units, batch count reconciliation, compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and terminal sterilization in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards. The Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor.
Essential Duties And Responsibilities
:
Understand and follow current Good Manufacturing Practices (GMP)
Understand and follow current Good Documentation Practices (GDP)
Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas. Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule.
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 and instruments.
Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality impact to the batch.
Perform routine operations utilizing aseptic formulation and filling equipment in Cleanroom 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 may be required
Successful operator qualification/media fill performance required to achieve increased operator levels
Job Requirements (Education, Experience And Qualifications)
:
High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred.
Must be able to understand, speak, read and write English in order to comply with necessary SOP's, job-specific training materials, GMP's, and other manuals.
Basic Computer skills in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Blue Mountain, etc.)
Must have the ability to work effectively in a "hands on environment" capable of troubleshooting complex equipment and systems
Competency in operation 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 to demonstrate proficiency in reading equipment drawings. Ability to work safely with equipment under pressure.
Physical / Safety Requirements
:
Must be able to lift and carry up to 50 lbs, and push and pull up to 50 lbs.
Extended periods of standing and/or walking
Extended periods in Grade A, B, C, D production environments
Use of hands and fingers to manipulate equipment is required
In return, you'll be eligible for:
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. Employees must be in their current position for a minimum of twelve (12) months and be in good standing before applying for other internal opportunities.
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.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy.
Bloomington, Indiana, United States
The Filling & Capping Operator (Operator II & III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, operating fill line equipment, conducting inspections of filled units, batch count reconciliation, compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and terminal sterilization in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards. The Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor.
Essential Duties And Responsibilities
:
Understand and follow current Good Manufacturing Practices (GMP)
Understand and follow current Good Documentation Practices (GDP)
Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas. Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule.
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 and instruments.
Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality impact to the batch.
Perform routine operations utilizing aseptic formulation and filling equipment in Cleanroom 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 may be required
Successful operator qualification/media fill performance required to achieve increased operator levels
Job Requirements (Education, Experience And Qualifications)
:
High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred.
Must be able to understand, speak, read and write English in order to comply with necessary SOP's, job-specific training materials, GMP's, and other manuals.
Basic Computer skills in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Blue Mountain, etc.)
Must have the ability to work effectively in a "hands on environment" capable of troubleshooting complex equipment and systems
Competency in operation 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 to demonstrate proficiency in reading equipment drawings. Ability to work safely with equipment under pressure.
Physical / Safety Requirements
:
Must be able to lift and carry up to 50 lbs, and push and pull up to 50 lbs.
Extended periods of standing and/or walking
Extended periods in Grade A, B, C, D production environments
Use of hands and fingers to manipulate equipment is required
In return, you'll be eligible for:
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. Employees must be in their current position for a minimum of twelve (12) months and be in good standing before applying for other internal opportunities.
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.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy.