Manufacturing Associate

Job Title: Manufacturing Associate Job Description This role supports a leading biotechnology manufacturing facility that produces gene therapy products used to treat rare and genetic diseases. As a Manufacturing Associate, you will perform daily production activities in a highly regulated, cleanroom environment, strictly following cGMP standards, standard operating procedures, and detailed work instructions.

You will operate manufacturing equipment, complete accurate documentation and batch records, maintain inventory records, and ensure all processes meet quality and regulatory requirements. Success in this position requires strong attention to detail, documentation accuracy, and the ability to work efficiently while following procedures exactly as written. Responsibilities Perform daily manufacturing operations in a cGMP-regulated biotechnology facility, producing gene therapy products according to established procedures.

Work primarily within cleanroom manufacturing suites while following strict gowning procedures and consistently wearing required personal protective equipment. Operate manufacturing and process equipment safely and effectively, including starting, monitoring, adjusting, and shutting down equipment as required. Follow standard operating procedures (SOPs), work instructions, and batch records exactly as written to maintain product integrity and regulatory compliance.

Complete documentation and batch records accurately, including production records, logbooks, and electronic entries, ensuring all data is clear, complete, and compliant with cGMP requirements. Maintain inventory records for materials, components, and supplies used in manufacturing, ensuring accurate tracking and traceability. Support routine troubleshooting of equipment and processes, and assist with preventative maintenance activities as directed.

Adhere to aseptic and sterile manufacturing practices, including proper gowning, cleanroom behavior, and contamination control procedures. Participate in quality-focused activities such as following CAPA-related instructions and nonconformance procedures as needed. Comply with all safety, quality, and regulatory policies, including proper handling of materials and equipment in a highly controlled environment.

Collaborate with team members in a fast-paced yet controlled production setting to meet production schedules and throughput goals. Adapt to process changes by learning updated procedures and implementing them consistently in daily work. Use computer-based systems for documentation, inventory tracking, and manufacturing execution, ensuring timely and accurate data entry. Stand for extended periods and perform physical tasks such as lifting materials, moving equipment components, and working in varying temperatures within the manufacturing suites.

Participate in audits, inspections, and other quality oversight activities by maintaining a constant state of inspection readiness and demonstrating adherence to procedures. Essential Skills At least 1 year of experience in manufacturing, production, laboratory, or operations, preferably within a GMP-regulated environment. High school diploma or GED. Experience working in a regulated environment such as pharmaceutical, biotechnology, medical device, food manufacturing, or chemical manufacturing.

Ability to work in a cGMP environment and follow strict quality and compliance requirements. Ability to wear PPE consistently, including hair nets, gloves, masks, coveralls, and other gowning components. Demonstrated documentation competency, including accurate completion of batch records, production records, logbooks, and other quality documents. Experience following SOPs and work instructions and executing processes exactly as written.

Mechanical and technical aptitude, including operating production machinery and process equipment and supporting basic troubleshooting. Strong attention to detail and accuracy in all tasks, especially documentation and process ex