For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

Summary

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.

Essential Duties and 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. 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 members
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

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.

Qualification Requirements: 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 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

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.

Physical Demands

• Occasional (1-33%)
  • Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
  • Lifting and carryingup to 70 lbs
  • Pushing 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

Additional Requirement: 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.

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 Law
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Pay 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 thelink 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