Formulation Technician I (2nd & 3rd Shifts)

Leiters Health; Denver (CO); On-site; USD 30,000 - 39,000; Full time

Benefits offered by this job

2nd shift differential $2/hr

3rd shift differential $3/hr

Job summary

Leiters Health is seeking a Formulation Technician to setup, prepare, and formulate bulk sterile drug products within the Aseptic Formulation Area, ensuring documentation and quality control follow cGMP standards.

The role requires handling sterilization equipment, maintaining traceability, and supporting calibration and maintenance activities. Strong English communication and attention to detail are essential for success on the manufacturing floor.

Qualifications

• Proficient aseptic technique and documentation practices.
• Familiarity with cGMP/GDP principles preferred.
• Able to follow SOPs and batch records accurately.

Responsibilities

• Set up, prepare, and formulate bulk sterile products.
• Operate aseptic equipment including biosafety cabinets and autoclaves.
• Maintain accurate documentation and traceability of materials.
• Assist in equipment calibration, validation, and preventive maintenance.
• Train team members and ensure adherence to safety policies.

Skills

Aseptic techniques

Documentation accuracy

Attention to detail

English communication

Education

High school diploma or GED

Tools

SOP training software

Microsoft Outlook

Cleanroom equipment

Job description

This position reports directly to the Manufacturing Supervisor. The Formulation Technician is responsible for the setup, preparation, and formulation of bulk sterile drug product(s) including the completion of associated documentation within the Aseptic Formulation Area.

Essential Functions

• Follow SOPs, product batch record instructions, and corresponding quality documentation.
• Set up and operate formulation, decontamination, and sterilization equipment such as heating stir plates, scales/balances, pH meters, biosafety cabinets, isolators, autoclaves, and depyrogenation ovens.
• Prepare and maintain accurate documentation following cGMP and GDP principles.
• Ensure proper accountability and traceability of components, ingredients, and finished products.
• Report and make recommendations regarding equipment, facilities, supplies, required repairs, process concerns, safety concerns, and areas for improvement in quality, yield, and efficiency.
• Recognize process errors and/or equipment malfunctions and notify supervision accordingly.
• Utilize and handle appropriate supplies and raw materials with proper aseptic manufacturing techniques.
• Support equipment calibration, equipment/utility validation, and preventive maintenance as needed.
• Clean and disinfect cleanrooms, equipment, and supplies in support of routine production.
• Training of team members following certification, as needed.
• Adhere to facility safety policies and procedures and proactively identify unsafe conditions.
• Other duties as assigned.

SUPERVISORY RESPONSIBILITIES

• N/A

EXPERIENCE AND NECESSARY COMPETENCIES

• High school diploma or GED required.
• Understanding of scientific formulations, aseptic techniques/environments, and cGMP requirements preferred.
• 1+ years of manufacturing experience in a regulated environment preferred.
• Ability to manage multiple priorities, maintain attention to detail, and ensure timely completion of tasks.
• High integrity and ability to work in changing environments.
• Good interpersonal and communication skills both verbal and written.
• Proficient written, verbal and oral English communication skills are required.
• Basic computer skills including use of SOP training software and Microsoft Outlook required.

Physical Requirements

• Ability to stand or sit for extended periods of time.
• Ability to lift, push and pull up to 50 pounds periodically.
• Ability to meet a gowning requirement for ISO 8 area and aseptic practices within an ISO 5 hood.

Hiring for the following shifts

2nd shift - Monday-Friday 3:30pm-12:00am; +$2.00/hour shift differential

3rd shift - Monday-Friday 11:30pm-8:00am; +$3.00/hour shift differential