Aseptic Technician I

RiseMe; Maryland; On-site; USD 42,000 - 66,000; Full time

Job summary

RiseMe is seeking a 3rd shift Aseptic Technician I to perform department tasks per cGMPs and site procedures in a clean room setting. You will blend vaccines, prepare batches, and operate various equipment under strict quality controls.

Responsibilities include following SOPs, maintaining batch records, and collaborating across departments to ensure safe, compliant production. Strong math, science, and communication skills are essential.

Qualifications

• High school education or GED required.
• Post High School education in the Sciences or other related disciplines preferred.
• Good mathematical, science and computer skills preferred.
• Demonstrated teamwork and collaboration skills required.
• Strong communication skills required.

Responsibilities

• Execution of aseptic techniques and clean room procedures or support area procedures in a GMP facility.
• Maintain appropriate departmental cGMP documentation.
• Execute all written procedures, to include Batch Records and SOPs.
• Follow and comply with all financial procedures.
• Follow and comply with all site safety procedures.
• Operation of departmental equipment to include set up and take down.
• Effectively work in a team environment and communicate with multiple departments.
• Stage inventory to consume into a blend by following manufacturing directions.
• Use aseptic processing skills while working in a clean room to assemble a vaccine and/ or large volume vaccine assembly in a class D environment.
• Maintain accurate inventory.
• Set up, run, tear down of various equipment involved such as: scales, mills, homogenizers, pumps, transfer lines, tanks, etc.

Skills

Aseptic techniques

cGMP compliance

Teamwork

Communication skills

Math & science literacy

Computer skills

Education

High school diploma or GED

Post-secondary science education preferred

Job description

Position Summary:

This 3rd shift Aseptic Technician I is responsible for executing department specific tasks in accordance with all applicable cGMPs and compliant with Corporate/site procedures, regulations, and policies.

Blending:

Formulate and prepare vaccines for the filling department. Includes batching antigens and excipients together per our regulatory filings and local procedures in a clean room setting or other classified areas. Involves work with portable and stationary equipment, and steam.

Working Hours:

• Sunday - Thursday, 10:00 PM - 6:30 AM
• OR
• Monday - Friday, 2:00 AM - 10:30 AM

Position Responsibilities:

• Execution of aseptic techniques and clean room procedures or support area procedures in a GMP facility.
• Maintain appropriate departmental cGMP documentation.
• Execute all written procedures, to include Batch Records and SOPs.
• Follow and comply with all financial procedures.
• Follow and comply with all site safety procedures.
• Operation of departmental equipment to include set up and take down.
• Effectively work in a team environment and communicate with multiple departments.

Blending:

• Stage inventory to consume into a blend by following manufacturing directions.
• Use aseptic processing skills while working in a clean room to assemble a vaccine and/ or large volume vaccine assembly in a class D environment.
• Maintain accurate inventory.
• Set up, run, tear down of various equipment involved such as: scales, mills, homogenizers, pumps, transfer lines, tanks, etc.

Education and Experience:

• High school education or GED required.
• Post High School education in the Sciences or other related disciplines preferred.
• Good mathematical, science and computer skills preferred.
• Demonstrated teamwork and collaboration skills required.
• Strong communication skills required.

Physical Requirements:

• Must be able to sit, stand, and walk for long periods of time.
• Must be able to wear a respirator.
• Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
• Must be able to work scheduled 40 hours with the ability to work overtime as needed.
• Must be comfortable in working in varying temperatures.
• Frequent lifting and carrying of 5 to 25 lbs.
• Regular reaching, bending, stooping, and twisting.
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.

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