What are the responsibilities and job description for the ARx Packaging Process Engineer position at ARx?
Job Description
Job Description
Job Summary :
Responsible for developing, scaling up and validating processes used for packaging specialty drug delivery products in a manner compliant with 21CFR211 and all other relevant regulatory requirements.
Essential Functions :
- Develops modified and new processes for Packaging and Serializing specialized drug delivery therapeutic products. Works in close collaboration on cross-functional teams with R&D, Quality, Operations, Marketing and Clients to accomplish successful outcomes.
- Performs a variety of engineering tasks with Senior Engineer guidance, which include but are not limited to preparation of experimental and validation protocols and execution thereof in the Packaging areas 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.
- Generates design records required to support product development and commercial production.
- Accurately performs work assignments and computer data analysis.
- Experience with Serialization and Anti-counterfeiting technologies.
- Effectively communicates and interacts with other associates and customers.
- Participates in problem-solving and equipment trouble shooting 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 :
Job Specifications :
