Formulation Operator (3rd Shift)

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 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.

The responsibilities :

• Understand and follow current Good Manufacturing Practices (cGMP).
• 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

The 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 :

Physical / safety requirements :

Sitting, climbing stairs and ladders, balancing, kneeling, operating controls

Standing, walking, reaching forward and overhead, stooping, crouching,

Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirements :

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

Medical & Dental Coverage

Spouse Life Insurance

Paid Holidays

Voluntary Insurance Benefits

Vision Coverage

Workout Facility

1] Current benefit offerings are in effect through 12 / 31 / 24

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.

EEO is the Law

EEO is the law - Poster Supplement

Pay Transparency Policy

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