Operations Tech Assistant (3rd Shift)

Role Summary

Operations Tech Assistant (3rd Shift) responsible for supporting injectable filling operations, setting up and changing over filling lines, and ensuring quality and regulatory compliance in a GMP manufacturing environment. Works on premise and collaborates with maintenance and engineering to troubleshoot equipment and optimize production. This role emphasizes safety, training, and continuous improvement to ensure medicines reach patients when needed. Location: On Premise.

Responsibilities

• Setting up and changing over the filling lines per approved procedures
• Monitoring filling line for efficient run time versus established standards
• Processing of hazardous and non-hazardous drug products into final containers
• Routine cleaning and sanitization
• Ensuring adequate inventory of parts and materials prior to initiating a production run
• Utilizing computer skills to interact with multiple complex PLC and SCADA systems
• Collaborating with maintenance and engineers to troubleshoot equipment and perform total productivity maintenance (TPM) tasks
• Supporting development and execution of Capital Projects, corrective actions, and continuous improvement ideas
• Demonstrating growth mindset to share best practices, utilize downtime effectively, and learning filling principles
• Working safely and compliantly following all applicable SOPs and standards including recording of GMP documentation
• Achieving and maintaining aseptic certification to work within graded spaces
• Completing and maintaining all required training on time
• Adheres to all area standard work
• Demonstrating ownership and accountability of the production schedule and product quality
• Executing in-process quality verifications and sampling

Qualifications

• Required: High School Diploma or GED with 2+ years of relevant experience
• Required: Analytical and problem-solving skills
• Required: Excellent communication and interpersonal skills
• Required: Ability to work independently and as part of a team
• Required: Detail-oriented with strong organizational skills
• Preferred: Previous experience in a cGMP environment
• Preferred: Proficiency in using manufacturing software and tools
• Preferred: Ability to adapt to changing priorities and work in a fast-paced environment
• Preferred: Demonstrated leadership skills and ability to mentor team members