Simtra BioPharma Solutions
Filling Operator (2nd shift - Weekends)
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
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Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra? Because we:
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
This role:
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.
This position is required to work all designated plant holidays.
2nd shift, Weekends: every Saturday/Sunday 3:00pm - 1:30am, plus 2 weekdays (either Mon/Tues or Thurs/Fri) 3:00pm - 11:30pm.
Its responsibilities:
Understand and follow current Good Manufacturing PracticesPerform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade A/B 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 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 membersRequired to maintain attendance in accordance with the Bloomington Attendance PolicyScheduled weekend overtime will be requiredThe work environment:
Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.
Desirable qualifications:
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions:
Ability to work independentlyGood communication skillsGood documentation skills, including legible handwritingGood interpersonal skillsBasic computer skillsBasic math skillsKnowledge of aseptic manufacturing practicesKnowledge of standard operating procedures, specifications, and job-specific training materialsRequires 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 devicesPhysical / safety requirements:
Occasional (1-33%)
Sitting, climbing stairs and ladders, balancing, kneeling, operating controlsLifting and carrying up to 70 lbsPushing and pulling up to 35 lbs
Frequent (34-66%)
Standing, walking, reaching forward and overhead, stooping, crouching,Lifting and carrying up to 37 lbs
Constant (67-100%)
Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping
Final candidates for Filling Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.Additional requirements:
Education and experience - High School diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred.Language skills - must be able to understand, speak, read and write English in order to comply with necessary SOP', job-specific training materials, GMP's, and other manuals.In return, you'll be eligible for [1] :
Day One Benefits
Medical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life Insurance
Spouse Life InsuranceChild Life Insurance
Short and Long-Term Disability Insurance401(k) Retirement Savings Plan with Company MatchTime Off Program
Paid HolidaysPaid Time OffPaid Parental Leave and more
Adoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service Program
Additional Benefits
Voluntary Insurance Benefits
Vision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and more
Onsite Campus Amenities
Workout FacilityCafeteriaCredit Union
[1] Current benefit offerings are in effect through 12/31/24
Equal Employment Opportunity
Simtra is 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.
EEO is the LawEEO is the law - Poster SupplementPay Transparency Policy
Reasonable Accommodations
Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra? Because we:
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
This role:
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.
This position is required to work all designated plant holidays.
2nd shift, Weekends: every Saturday/Sunday 3:00pm - 1:30am, plus 2 weekdays (either Mon/Tues or Thurs/Fri) 3:00pm - 11:30pm.
Its responsibilities:
Understand and follow current Good Manufacturing PracticesPerform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade A/B 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 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 membersRequired to maintain attendance in accordance with the Bloomington Attendance PolicyScheduled weekend overtime will be requiredThe work environment:
Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.
Desirable qualifications:
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions:
Ability to work independentlyGood communication skillsGood documentation skills, including legible handwritingGood interpersonal skillsBasic computer skillsBasic math skillsKnowledge of aseptic manufacturing practicesKnowledge of standard operating procedures, specifications, and job-specific training materialsRequires 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 devicesPhysical / safety requirements:
Occasional (1-33%)
Sitting, climbing stairs and ladders, balancing, kneeling, operating controlsLifting and carrying up to 70 lbsPushing and pulling up to 35 lbs
Frequent (34-66%)
Standing, walking, reaching forward and overhead, stooping, crouching,Lifting and carrying up to 37 lbs
Constant (67-100%)
Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping
Final candidates for Filling Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.Additional requirements:
Education and experience - High School diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred.Language skills - must be able to understand, speak, read and write English in order to comply with necessary SOP', job-specific training materials, GMP's, and other manuals.In return, you'll be eligible for [1] :
Day One Benefits
Medical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life Insurance
Spouse Life InsuranceChild Life Insurance
Short and Long-Term Disability Insurance401(k) Retirement Savings Plan with Company MatchTime Off Program
Paid HolidaysPaid Time OffPaid Parental Leave and more
Adoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service Program
Additional Benefits
Voluntary Insurance Benefits
Vision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and more
Onsite Campus Amenities
Workout FacilityCafeteriaCredit Union
[1] Current benefit offerings are in effect through 12/31/24
Equal Employment Opportunity
Simtra is 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.
EEO is the LawEEO is the law - Poster SupplementPay Transparency Policy
Reasonable Accommodations
Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy