Clean Room Associate

Clean Room - Compo under (1st Shift)

The 1st Shift (7:00am-3:30pm) Fill / Mixer Operator works in a sterile, FDA-regulated pharmaceutical manufacturing environment to compound, mix, and fill sterile medications in accordance with Good Manufacturing Practices (GMP). This role focuses on operating formulation and filling equipment, performing meticulous cleaning and sanitization, completing accurate documentation, and supporting production goals while maintaining the highest standards of safety and quality. We are looking for individuals to interview and start as soon as possible.

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Responsibilities

• Perform daily cleaning and sanitization of production equipment and manufacturing areas to maintain sterile conditions and comply with GMP requirements.
• Complete all required GMP documentation and batch records accurately and legibly, following recipes and batch instructions for raw materials, active pharmaceutical ingredients (APIs), and excipients.
• Perform batch compounding and mixing of sterile pharmaceutical products in accordance with established procedures and quality standards.
• Operate formulation systems, human machine interfaces (HMIs), and computerized manufacturing equipment to support production activities.
• Assemble production equipment including filters, clamps, gaskets, and related components, ensuring correct setup and integrity.
• 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 and properly using required personal protective equipment (PPE), including gowning and respirators.
• Utilize computer systems to access SOPs, training modules, and document management systems, and to enter production and quality-related data.
• Support daily and long-term production goals by maintaining throughput, minimizing downtime, and collaborating with team members.
• Perform visual inspection of products and components to identify defects, contamination, or deviations from specifications.
• Apply strong attention to detail to ensure product quality, compliance with FDA and GMP regulations, and adherence to safety protocols.
• Handle materials and finished products safely and efficiently within a highly regulated manufacturing environment.
• Stand and walk throughout the entire shift while performing tasks that may include lifting up to 40 pounds.
• Participate in ongoing training and development activities to maintain compliance and expand technical skills.

Essential Skills

• Previous GMP manufacturing experience in a regulated environment.
• Experience with batch mixing, compounding, or following recipes and batch records in a production setting.
• Strong documentation skills with the ability to complete GMP records accurately and consistently.
• Proficiency using computer systems to access SOPs, training modules, and document management systems.
• 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 demonstrated commitment to product quality and safety.
• Comfort working in full PPE, including gowning and respirators, in sterile and isolator environments.
• Ability to perform visual inspection of products and components for defects or deviations.
• Understanding of FDA-regulated manufacturing practices or willingness to work within FDA-regulated processes.

Additional Skills & Qualifications

• Experience with pharmaceutical batch compounding, mixing, and formulation systems.
• Familiarity with HMIs and computerized manufacturing equipment.
• Knowledge of FDA regulations and quality systems in pharmaceutical manufacturing.
• Experience in packaging, quality inspection, labeling, and cleaning in a production environment.
• Comfort working in a temperature-controlled, multi-floor facility.
• Ability to follow detailed SOPs and work instructions with consistency and accuracy.
• Strong teamwork, communication, and reliability in a production environment.

Why Work Here?

This direct hire opportunity offers long-term career growth in a state-of-the-art pharmaceutical manufacturing environment where safety and quality are top priorities. Employees receive comprehensive training, clear advancement pathways, and the chance to contribute to…