Formulation Technician Tier I, II, III; Shift 3 and 4

Description Tier 1 – Formulation Technician I (Entry-Level)

• Adherence to safety protocols and proper use of PPE.
• Adherence to Good Documentation Practices and Current Good Manufacturing Practice regulations.
• Complete and maintain applicable training certifications.
• Proper time management, including arriving on time, observing appropriate breaks – including lunches – as well as minimizing overtime unless authorized by management.
• Any deviation from the assigned schedule must be communicated to management, including call‑outs.
• Complete assigned tasks on production schedule in an efficient manner.
• Complete dispensing, formulation, filter integrity testing, sample submission and all other supporting processes per applicable batch records, procedures, or forms.
• Ability to properly enter clean rooms, maintain gown certification requirements, and demonstrate proper cleanroom environment behavior – such as aseptic technique.
• Operate and navigate software systems including but not limited to:
  Lab Vantage, PIMS, Factory Talk, RMLA and E .
• Operate and navigate equipment such as balances, formulation tanks, filter integrity equipment, and pH meters.
• Coordinate and communicate with team members and other necessary departments in order to complete production tasks.
• Communicate shift activity as well as any obstacles, equipment issues, deviations, safety concerns or out of specifications to management and/or the appropriate personnel.
• Perform any other tasks as assigned by management or senior leadership.

• Budesonide Tier I Training – Completion of Budesonide Tier I training to understand specific handling and formulation requirements.
• Formulation Expertise – Gaining specialized knowledge and skills in pharmaceutical formulation through education and hands‑on experience.
• Portable and Large Tank Formulations – Skilled in preparing formulations using portable tanks and large‑scale tanks to ensure batch accuracy and quality.
• SALTUS and MOBIUS Formulation Tanks – Experience operating and managing formulations in SALTUS and MOBIUS tanks, understanding their specific capabilities and protocols.
• Good Documentation Practices (GDP) – Adherence to GDP standards to maintain accurate, compliant documentation throughout manufacturing processes.
• Pre‑weigh Procedures – Accurate pre‑weighing of raw materials to ensure formulation consistency.
• Filter Testing – Conducting filter integrity tests to meet sterility and quality standards.
• pH Meter Calibration – Performing calibration and operation of pH meters to control formulation parameters effectively.

Using nitrogen sparging techniques to reduce oxygen levels and enhance product stability.

• Containment Box & Data Logger – Skilled in operating containment box used for pre‑weighing raw materials under vacuum to minimize moisture exposure, along with using data loggers to monitor process conditions.
• Electronic Controlled Substance Waste Logbook – Maintain and manage accurate, compliant electronic records of controlled substance waste.
• Handling Controlled Substances – Thorough understanding of procedures for handling‑controlled substances.
• BFS (Blow‑Fill‑Seal) Process – Understanding of how BFS technology integrates with formulation processes.
• Carboy Handling – Skilled in preparation and management of carboys used in formulation processes.
• Accuflux Filter Testing Unit – Proficient in operating the Accuflux system for filter integrity testing to ensure product sterility and quality.
• Portable Tank CEV Sampling and Submission – Competent in collecting samples from portable tanks following Controlled Environmental Validation (CEV) standards and submitting samples correctly.
• Portable Tank Filtration – Ability to perform filtration on portable tanks while ensuring sterility and product quality.
• Large Tank CEV Sampling and Submission – Skilled in CEV‑compliant sampling from large tanks and proper sample submission procedures.
• Large Tank Filtration – Skilled in carrying out filtration processes on large tank formulations as part of daily manufacturing operations.
• Budesonide Tier II Training –…