ARx Technical Operator-1st Shift

Job Summary:

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.

Essential Functions:

• Work with the manufacturing and process engineers to develop modified and new processes for producing specialized drug delivery therapeutic products. Works in close collaboration on cross-functional teams with Engineering, Operations, and Quality to accomplish successful outcomes. Will work on the packaging line as needed.
• Provides oversight to packaging process, including spending significant time on the line and monitoring the process.
• Performs a variety of technical line tasks with Engineering and Operations guidance, which include but are not limited to the execution of experimental and validation protocols for packaging in compliance with 21CFR211 Regulatory standards.
• Contributes to designing experiments, conducts experiments, collects data and performs data analysis and interpretation. Generates reports and makes recommendations based on sound data interpretation.
• Contributes to generating cleaning processes and change over requirements.
• Contributes to design records required to support product development and commercial production.
• Accurately performs work assignments and collects information for computer data analysis.
• Effectively communicates and interacts with other associates and customers.
• Participates in problem-solving efforts.
• Proactively works to develop foundational knowledge base on relevant process technologies.
• Develops and maintains awareness of business strategies and plans.
• Conducts 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).

Additional Responsibilities:

• Supports deviation investigations; develops and implements preventative actions.
• Participates in training and supports the designs for equipment trainings.
• Supports the data collection for the design of equipment recipes for operation.
• Acts as line lead on the packaging line for manufacturing activities.
• Performs other duties and responsibilities as assigned.

Job Specifications:

• Requires an 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 but not limited to LEAN manufacturing principles, design control, validation, experimental design, etc.
• Excel, Word, PowerPoint, Outlook, Statistical software package capability.
• Ability to effectively organize thoughts, information and data; can 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 (<25%).
• Work environment may involve moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, 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.