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 cleanrooms, maintain gown certification requirements, and demonstrate proper cleanroom environment behavior – such aseptic technique.
-
Operate and navigate software systems including but not limited to: LabVantage, PIMS, FactoryTalk, RMLA and EBR.
-
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.
Tier 2 – Formulation Technician II (Intermediate)
-
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.
Nitrogen Sparge Application-Using nitrogen sparging techniques to reduce oxygen levels and enhance product stability
Tier 3 – Formulation Technician III (Advanced)
-
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-Completion of Budesonide Tier II training, reflecting advanced knowledge in formulation.
Skills:
-
Expertise regarding handling and mixing of chemicals through education and/or experience preferred.
-
Strong attention to detail, math skills, and knowledge of the metric system.
-
Ability and willingness to change direction and focus promptly to meet shifting organizational and business demands.
-
Ability to manage multiple resources in a cGMP environment to ensure documented information is accurate, legible, contemporaneous, original, and attributable.
-
Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting, walking, and hearing.
-
Ability to pass required medical screenings to ensure safe handling of pharmaceutical raw materials used within the manufacturing process.
-
Technicians are required to wear appropriate PPE and interpret documentation containing safety guidance.
-
Ability to work individually and as part of a team in order to create and contribute to an environment that values people and encourages trust, teamwork, and open communication.
-
Ability to effectively manage oneself, demonstrate integrity, be productive under pressure, and achieve developmental goals.
-
Ability to communicate effectively to team members and superiors
Abilities:
-
Ability to develop positive, professional relationships with senior leadership and peers in a heavily matrixed environment.
-
Ability to handle contending priorities and managing partner expectations.
-
Strong project management skills with ability to execute on short- and long-term deliverables.
-
Ability to combine Industry knowledge to appropriately evaluate and resolve complex issues within a fast paced and changing business environment.
-
Ability to objectively coach employees and management through complex, difficult, and emotional issues.
-
Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law.
Requirements:
Tier I and II: High School Diploma or GED
Tier III: Minimum of High School Diploma or equivalent with Associate or Bachelor’s Degree preferred.
Working Conditions / Physical Requirements:
- This position requires bending, typing, lifting (up to 20 1bs.), standing, sitting and walking throughout the facility.
