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 receive substantial paid time off, including vacation, personal days, and company-paid holidays, along with comprehensive health, dental, vision, mental health, disability, and life insurance coverage. Once hired into a permanent role, team members benefit from annual performance bonuses, commission and share potential, a competitive 401(k) program with a strong company match, and an employee discount and wellbeing rewards program. The organization invests heavily in its facilities and provides robust training, tuition reimbursement, and clear paths for career advancement, including yearly promotion opportunities. With a global manufacturing footprint and strong performance in the U.S. market, employees join a stable, growing company that values work-life balance, profe