Aseptic Filling Technician- 2nd Shift

Kindeva; Maryland Heights (MO); On-site; USD 36,000 - 48,000; Full time

Job summary

Kindeva is seeking a manufacturing technician to operate aseptically filled injectable product lines in a clean room, following cGMP and aseptic procedures. You will handle batch records, perform sanitation, and participate in process improvements to ensure product quality.

Strong reading, math, and computer skills are required, with gowning and respirator qualifications preferred. The role emphasizes adherence to GMP documentation, proper material handling, and teamwork within a highly

Qualifications

• Must read and comprehend instructions, correspondence and technical documents.
• Ability to perform basic mathematical calculations for unit accounting.
• Proficiency in operating computerized systems.

Responsibilities

• Operate filling and component assembly machines in a clean room.
• Follow cGMP and aseptic procedures.
• Document batch records, logbooks and GMP documents with accuracy.
• Maintain clean room environment and perform sanitation duties.
• Assist in process improvement activities and SOP adherence.

Skills

Reading comprehension

Basic math

Computer skills

Documentation

Aseptic techniques

Sterile gowning

Respirator use

Education

High school diploma or GED

Associate's degree

Tools

None

Job description

ROLE SUMMARY

Works in a clean room environment which requires gowning qualification and adherence to good aseptic techniques to produce aseptically filled injectable drug products. The position requires cGMP understanding and involves operating of the filling machines and aseptically assembling components used on some of the machines.

ROLE RESPONSIBILITIES

• Follows aseptic behavioral requirements.
• Follows cGMP requirements
• Operate component assembly machines and filling machines.
• Unload sterilizers, properly handle components and machine parts.
• Perform proper accountability & documentation batch records, logbooks, and other GMP documents)
• Works in a clean room environment.
• Perform cleaning and disinfection / sanitization of stationary equipment, room surfaces in all cGMP room areas to ensure compliance with all sanitization procedures to maintain a sterile environment.
• Perform appropriate department housekeeping duties per SOPs.
• Other duties as assigned (e.g., drug filtration, personnel plating, daily inventory clean room parts checks, etc.)
• Participate in process improvements activities.
• Will demonstrate behaviors aligned to the company's PRECISE Values.

BASIC QUALIFICATIONS

• High school diploma or general education degree (GED) or associate's degree.
• Must be able to read and comprehend instructions, correspondence, and technical documents.
• Must demonstrate the ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to perform calculations for percent accountabilities and reconciliation of numerical values.
• Proficiency in operating computerized systems and software.
• Must demonstrate the ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
• Must follow and review detailed documentation for accuracy and completeness.

TECHNICAL 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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
• Position requires bending, stooping, squatting, pull/push and reaching above the shoulder level.
• Ability to read and comprehend simple instructions, correspondence, and memos.
• Ability to write correspondence.
• Ability to effectively present information in one-on-one and small group situations to other employees of the organization.
• Must be able to pass Sterile gown and media fill qualification.
• Position may require use of a respirator.

PHYSICAL QUALIFICATIONS

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job.

1. 1. The employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls.
2. 2. The employee is regularly required to stand and walk; climb or balance; and stoop, kneel, crouch, or crawl.
3. 3. The employee must occasionally lift and/or move up to 40 pounds.
4. 4. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust and focus.
5. 5. Cannot be claustrophobic.
6. 6. Must achieve a score of 9 or above for near vision (14") with both eyes using a Titmus II vision tester.
7. 7. Position requires bending, stooping, squatting, pull/push and reaching above the shoulder level.
8. 8. The employee must wear all required safety equipment and perform assigned work in a safe manner.
9. 9. Employee must use proper lifting techniques and be conscious of hazards around him/her.