Responsible for providing quality engineering support to packaging operations as well to investigate, plan and implement product quality improvements and additions to current products and packaging processes that directly affect safety, quality, regulatory compliance and productivity.
- 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.
- 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.
- Assists in developing modified and new processes for quality systems related to producing specialized drug delivery therapeutic products. Works in close collaboration on cross-functional teams with Packaging, Operations, Engineering and Clients to accomplish successful outcomes.
- Performs a variety of engineering tasks, which include but are not limited the review of developmental and validation protocols and leads the execution thereof in the packaging areas in compliance with 21CFR211 Regulatory standards. Supports cleaning verification, validation, and re-validation efforts.
- Plans and executes quality sampling during GMP and commercial packaging production.
- Engages in deviation investigations and technical writing for 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.).
- 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 for packaging operations.
- 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