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.