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 Formulation Operator (Operator III) position will work in and maintain a Grade C/D environment. They will perform routine cleaning and sanitization to help ensure readiness and current Good Manufacturing Practices (cGMP) compliance within the classified and non-classified work areas. Activities include cGMP compliant gowning, conformance to Good Documentation Practices (GDP) standards, weighing materials, formulation of product, and conducting in-process testing and filtration. The Formulation 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 C/D 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 segregation, readiness and to prevent any contamination or rejection of batches.
• Compare Lot numbers to ensure correct material is being used for the specified batch
• Complete calculations to determine the amount of material to add based on final weight and sometimes potency
• Retrieve and test in-process samples 
• Use scales and balances to weigh and add wide range of raw material
• Clean and sample equipment 
• 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
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching, 
• Pushing and pulling up to 110 lbs
• Lifting and carrying up to 70 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional Requirement: Final candidates for Formulation 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 EEO is the law - Poster Supplement 
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 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