Formulation Technician

Laboratoire Guerbet•Raleigh, IL

8d•Onsite

About The Position

The Formulation Technician operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The Formulation Technician is responsible for the processing and preparation of pharmaceutical formulations within a cGMP regulated production environment. The role also provides operational support to filling team members, ensuring a smooth transition of materials and consistent execution of upstream and filling processes. The Formulation Technician will also be responsible for completing all necessary documentation related to the manufacturing process while adhering to cGMP and GDP guidelines.

Requirements

High School diploma, GED or equivalent.
Strong knowledge of aseptic processing, cleanroom standards, and sterile techniques.
Knowledge of basic computer skills and Microsoft Office.

Nice To Haves

1-3 experience in pharmaceutical manufacturing (preferred).
Compounding or formulation experience (preferred)

Responsibilities

Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in a clean room environment requiring aseptic behavior.
Prepare media according to approved batch records, SOPs, and cGMP requirements. Verify material identity, lot numbers, expiration dates, and required quantities through inventory systems, such as SAP
Perform controlled transfers of API into designated formulation vessels or staging containers while adhering to segregation, containment, and safety procedures.
Prepare and review process documentation to ensure accuracy, completeness, and compliance with cGMP and GDP requirements.
Ensure compliance with all applicable regulatory agencies and cGMP requirements. Sanitize hold tanks, formulation tanks, process equipment, utensils, and conduct general cleaning of formulation processing areas according to cGMP and sanitation procedures.
Maintain strict adherence to aseptic techniques during all operations within a controlled environment.
Ensure a high level of safety, quality, and productivity to maintain a reliable supply of products to patients.
Promptly report and assist in investigation of any contamination events or deviations.
Performs other duties as assigned by management
Collaborate with Engineering, Validation, and other departments in initiating and implementing programs such as Continuous Improvement (Lean and 5S) and Total Productive Maintenance.
Prevent excess waste of product and/or components by operating the equipment in an efficient manner.
Report all safety and/or environmental incidents to management immediately.
Cross-training to perform tasks and roles outside of the primary responsibilities.