ARx Technical Operator-1st Shift

About the Role

Responsible for assisting in developing, scaling up, and validating processes used for producing specialty drug delivery products in a manner compliant with 21CFR211 and all other relevant regulatory requirements on the ARx packaging lines.

Responsibilities

• Work with manufacturing and process engineers to develop modified and new processes for producing specialized drug delivery therapeutic products.
• Collaborate on cross-functional teams with Engineering, Operations, and Quality to accomplish successful outcomes.
• Provide oversight to the packaging process, including spending significant time on the line and monitoring the process.
• Perform technical line tasks with Engineering and Operations guidance, including execution of experimental and validation protocols for packaging in compliance with 21CFR211 Regulatory standards.
• Contribute to designing experiments, conduct experiments, collect data, and perform data analysis and interpretation.
• Generate reports and make recommendations based on sound data interpretation.
• Contribute to generating cleaning processes and changeover requirements.
• Contribute to design records required to support product development and commercial production.
• Accurately perform work assignments and collect information for computer data analysis.
• Effectively communicate and interact with other associates and customers.
• Participate in problem-solving efforts.
• Proactively develop foundational knowledge base on relevant process technologies.
• Develop and maintain awareness of business strategies and plans.
• Conduct all work activities in a safe, responsible, and professional manner consistent with all Company Policies, Quality Systems Requirements, and Relevant Regulatory Standards (e.g., 21CFR211).
• Support deviation investigations; develop and implement preventative actions.
• Participate in training and support the designs for equipment trainings.
• Support data collection for the design of equipment recipes for operation.
• Act as line lead on the packaging line for manufacturing activities.
• Perform other duties and responsibilities as assigned.

Requirements

• Associates degree in a technical competency or 5-10 years of mechanical/maintenance work on packaging equipment.
• cGMP manufacturing environment experience desirable.
• Capable of learning practical application of technical skills in areas including LEAN manufacturing principles, design control, validation, and experimental design.
• Proficiency in Excel, Word, PowerPoint, Outlook, and statistical software packages.
• Ability to effectively organize thoughts, information, and data; articulate and convey them (oral and written) concisely and clearly to others.
• Ability to manage several priorities simultaneously.
• Time flexibility to occasionally work extended hours as business demands.
• This is an off-shift opportunity.
• Must be able to travel as needed to support the business.
• Work environment may involve moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, or chemical irritants; may be required to use personal protective equipment such as masks, uniforms, blues, hairnets, gloves, safety glasses/goggles, shields, etc.
• Ability to function effectively with others in a team environment.