ARx Process Engineer lll

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. Responsible for providing technical oversight to production of developmental, scale up and validation materials.

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, 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.
• Designs and conducts experiments, collects data and performs data analysis and interpretation using statistical tools (SPC, ANOVA, Regression, etc.). Generates reports and makes decisions based on statistical data interpretation.
• Generates design records required to support product development and commercial production.
• Proficiently employs current software tools for communications, presentations, engineering, project tracking and statistical analysis (e-mail; spreadsheets; PowerPoint, Project Management, Experimental Design, Statistical tools, etc.).
• Effectively communicates with other associates, Engineers, Supervisors, Product Development Scientists and Customer Logistics Coordinators while maintaining the self-confidence and self-esteem of others; voluntarily assists other associates, and communicates effectively to prevent problems from occurring.
• Leads problem-solving efforts and takes initiative to make changes through change control procedures.
• Continually improves fundamental process technology expertise and effectively builds knowledge base in co-workers. Maintains, extends and utilizes technology in a way that results in consistent and significant impact on existing and new businesses within the company. Leads and/or collaborates on the innovation of new product and processes technologies.
• Influences business strategies that have both divisional and corporate impact. Participates in strategic technology planning for business units and corporate platforms.
• 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:

• Networks across functions and corporately to meet business objectives. Proactively facilitates sharing of technology inside the company and shares information responsibly with external contacts.
• Provide technical support to internal and external customers on process and equipment capabilities and quality issues. Conducts deviation investigations as assigned; develops and implements preventative actions.
• Participates in training; assists with and leads training, where applicable. Mentors team members and other engineers to increase their functioning capabilities.
• Assume Operations Managers/Supervisors roles as designee when managers are out the office.
• Performs other duties and responsibilities as assigned
• Provide technical oversight and direction to Operation's associates during production of developmental, scale up and validation materials.
• Performs other duties and responsibilities as assigned.

Job Specifications:

• Requires Bachelors degree in an Engineering discipline (Chemical preferred); other technical degrees will be considered depending on complement of relevant experience & capabilities
• Minimum of five (5) years experience in cGMP manufacturing environment.
• Supervision experience required, manufacturing supervision experience preferred.
• Engineering principles, concepts and methodology expertise with well-established abilities supported by examples for applying them in relevant application problem solving and root cause analysis.
• Fundamental expertise in mixing, coating and finishing process technologies.
• Expertise in Lean manufacturing, design control, design records, cGMP and FDA protocols, cleaning validation, process validation, statistically-based experimental design (DOE), statistical analysis, Quality-By-Design (QBD) and Process Analytical Technology (PAT). Familiarity with some regulatory filing elements such as Chemistry, Manufacturing and Controls (CMC).
• Excel, Word, PowerPoint, Outlook, Statistical software package proficiency.
• Exceptional ability to effectively organize thoughts, information and data; can articulate and convey them (oral and written) concisely and clearly to others. Ability to develop and present effective technical presentations to internal and external audiences.
• Self-reliant; motivated; highly organized Engineering Professional; experienced in balancing internal and external customer technical and engineering support needs; process optimization, problem solving, training, project planning and prioritization; ongoing team participation and communications (oral and written).
• 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 (
• Work environment may involve moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, and chemical irritants; may be required to use personal protective equipment such as masks, uniforms, blues, hairnets, gloves, safety glasses/goggles, shields, etc.
• Superior interpersonal skills; role model whose qualities exemplify a well-balanced and effective leader and serves as a resource for the company; ability to comfortably, effectively communicate with all levels and functions - especially floor operational and customer personnel.