Formulation Technician

Formulation Technician

The Formulation Technician is a hands-on member of the Operations Team responsible for supporting dispensing, formulation, documentation, cleaning, restocking, and production support activities within a 503B pharmaceutical manufacturing facility. This role primarily works in a classified ISO-8 environment and requires employees to follow detailed procedures, wear appropriate PPE, complete documentation accurately and contemporaneously, and maintain a strong focus on cGMP, GDP, safety, quality, and patient safety expectations.

This position is a good fit for someone who has prior sterile compounding, pharmaceutical manufacturing, or regulated production experience and is comfortable performing detail-heavy, procedure-driven work in a controlled environment.

What This Role Does Day-to-Day

In this role, the Formulation Technician may support ISO-8 dispensing and formulation operations, material preparation, equipment setup, batch record execution, documentation, cleaning, and other production support tasks. Daily work may include weighing or measuring materials, preparing components for formulation, following batch records step by step, using equipment according to training, and escalating any process, documentation, equipment, or safety concerns before proceeding.

The role requires strong attention to detail, comfort with PPE and gowning requirements, basic arithmetic and chemistry-related calculations, clear communication, and the ability to work carefully in a fast-paced environment with changing priorities. Candidates should understand that even small errors in documentation, calculations, materials, or procedure execution can impact product quality and patient safety.

Key Responsibilities

• Perform ISO-8 dispensing and formulation operations according to batch records, SOPs, work instructions, protocols, and applicable cGMP requirements.
• Prepare, verify, handle, and stage materials, components, product containers, and equipment needed for formulation activities.
• Weigh, measure, dispense, or support formulation-related tasks using approved procedures, training, and required documentation.
• Use relevant manufacturing equipment, tools, and technology according to established procedures and qualification requirements.
• Accurately and contemporaneously document all actions performed in accordance with GDP standards, ensuring entries are complete, legible, clear, and attributable.
• Recognize and appropriately respond to potential deviations, calculation concerns, documentation errors, equipment issues, material discrepancies, or process questions; obtain clarification from leadership before proceeding.
• Follow all cGMP, health, safety, PPE, gowning, OSHA, EPA, RCRA, DEA, FDA, and company policy requirements.
• Safely handle chemicals, corrosives, solvents, pharmaceutical compounds, and other materials according to approved procedures.
• Assist with classified and non-classified area cleaning, sanitization, restocking, and maintenance as required.
• Support visual inspection, labeling, packaging, and other production activities as assigned based on business need.
• Complete required training and qualifications within expected timelines and maintain qualification for assigned job tasks.
• Maintain a quality-focused, right-first-time mindset and understand the direct impact of the role on product quality and patient safety.
• Communicate effectively across shifts and with Production, Quality, leadership, and other departments as needed.
• Make recommendations for process improvements and speak up about viable options for safer, more compliant, or more efficient processes.
• Perform other duties as assigned based on business and production needs.

What Success Looks Like

• Arrives on time and is prepared to work in a classified environment for the majority of the shift.
• Follows written procedures exactly and asks for clarification before proceeding when unsure.
• Maintains focus and accuracy during detail-heavy dispensing, formulation, cleaning, and documentation tasks.
• Completes documentation accurately, contemporaneously, and in alignment with GDP/cGMP expectations.
• Understands that patient safety and product quality depend…