What are the responsibilities and job description for the Process Engineer position at ARx, LLC?
Job Summary:
Responsible for 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.
Essential Functions:
Develops modified and new processes for producing 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 chemical processing , coating and slitting/finishing 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.
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:
Conducts deviation investigations; develops and implements preventative actions.
Participates in training.
Performs other duties and responsibilities as assigned.
Job Specifications:
Requires Bachelors degree in an Engineering (Chemical preferred).
cGMP manufacturing environment experience desirable.
Engineering principles, concepts and methodology foundational knowledge and ability to practically apply them.
Capable of learning practical application of engineering 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 and/or different shifts as programs and business demands. 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.
