Formulation Technician

About the role

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.

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

Qualifications

• High School diploma, GED or equivalent.
• 1-3 experience in pharmaceutical manufacturing (preferred).
• Compounding or formulation experience (preferred)
• Strong knowledge of aseptic processing, cleanroom standards, and sterile techniques.
• Knowledge of basic computer skills and Microsoft Office.

Physical Requirements

• Ability to stand for extended periods of time.
• Must be able to continuously lift a minimum of 50 Ibs.
• Ability to operate an electric pallet jack.
• Must be physically able to wear full aseptic gowning, including gloves, mask, and other protective gear, for extended periods while working in a controlled cleanroom environment.

Benefits

As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.