Process Engineer II
Process Engineer II
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 during production of developmental, scale up and validation trials.
- 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 leads the 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.
- Participates in problem-solving and takes initiative to make changes through change control procedures.
- Develops increasing expertise in fundamentals of relevant process technologies. Recognizes and acts on opportunities to apply know-how on programs. Contributes to the innovation of new product and processes technologies
- Maintains awareness of business strategies and plans; aligns day-to-day program support activities with same.
- 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).
- Provide technical oversight and direction to Operation’s associates during production of developmental, scale up and validation trials.
- Networks across functions to meet business objectives. Proactively shares 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 and assists with training, where applicable.
- Performs other duties and responsibilities as assigned
- Requires Bachelors degree in an Engineering (Chemical preferred) or other Technical discipline when coupled with relevant expertise.
- Two (2) years minimum experience in cGMP manufacturing environment.
- 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.
- Mixing, coating and finishing process technologies know-how desired.
- Training and/or experience in cGMP and FDA protocols, cleaning validation and process validation; preferably also have experience with design control, statistically-based experimental design (DOE), statistical analysis, Quality-By-Design (QBD), Process Analytical Technology (PAT), Risk Analysis and LEAN manufacturing.
- Excel, Word, PowerPoint, Outlook, Statistical software package proficiency.
- Ability to effectively organize thoughts, information and data; can articulate and convey them (oral and written) concisely and clearly to others.
- Ability to effectively prioritize workload and effectively leads multiple tasks and projects 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.