Mixer Operator

Job Description

Job Description

Job Title: 1st Shift Fill Operator

Job Description

The 1st Shift Fill Operator plays a key role in sterile pharmaceutical manufacturing by preparing, compounding, and filling products in a highly regulated cleanroom environment. This position focuses on safe and accurate batch production, meticulous documentation, and adherence to Good Manufacturing Practices (GMP) to ensure high-quality medications that directly support patient care.

Responsibilities

• Perform daily cleaning and sanitization of production equipment and manufacturing areas to maintain a sterile and compliant environment.
• Complete required GMP documentation and batch records accurately, including details related to raw materials, active pharmaceutical ingredients (APIs), and excipients according to recipes and batch instructions.
• Perform batch compounding and mixing of sterile pharmaceutical products following established procedures and quality standards.
• Operate formulation systems, human-machine interfaces (HMIs), and computerized manufacturing equipment to support production activities.
• Assemble production equipment components such as filters, clamps, and gaskets to prepare lines for manufacturing runs.
• Conduct filter integrity testing and flushing procedures to verify equipment performance and product safety.
• Follow standard operating procedures (SOPs) for material handling, equipment setup, cleaning, and production processes.
• Work in sterile cleanroom and isolator environments while consistently wearing required personal protective equipment (PPE).
• Utilize computer systems to access SOPs, training modules, and document management systems, and to complete electronic documentation as needed.
• Support production goals by meeting output targets while maintaining the highest quality, safety, and compliance standards.
• Perform visual inspection of products and components to identify defects and ensure product quality.
• Assist with packaging, labeling, and quality inspection activities as required to support overall manufacturing operations.

Essential Skills

• Previous GMP manufacturing experience in a regulated environment.
• Experience with batch mixing, compounding, or following recipes and batch records.
• Strong documentation skills with the ability to complete GMP and batch records accurately and legibly.
• Proficiency using computer systems for documentation, training, and accessing SOPs.
• Ability to work effectively in a cleanroom or highly regulated manufacturing environment.
• High school diploma or GED.
• Ability to lift up to 40 pounds safely and repeatedly as needed.
• Ability to stand and walk throughout the entire shift.
• Strong attention to detail and a consistent commitment to quality and safety.
• Comfort working in gowning, respirators, and full PPE as required by cleanroom and FDA-regulated conditions.
• Capability to perform visual inspection to identify defects or irregularities in products.

Additional Skills & Qualifications

• Experience in sterile pharmaceutical manufacturing or similar FDA-regulated production environments.
• Experience in packaging, labeling, and quality inspection within a manufacturing setting.
• Familiarity with cleanroom protocols and aseptic techniques.
• Understanding of FDA regulations and quality standards related to pharmaceutical production.
• Ability to work with IV bags and injectable drug products in a controlled environment.
• Comfort operating HMIs and computerized manufacturing equipment.
• Willingness to learn new processes and adapt to additional production lines and shifts as the facility expands.

Why Work Here?

This direct hire opportunity offers long-term career growth in a state-of-the-art, FDA-regulated pharmaceutical manufacturing environment where safety and quality are top priorities. Employees…