Process Engineer III

We are partnered with an outstanding Pharmaceutical Manufacturing company located in Pennsylvania. They are looking to bring on a Process Engineer III to join their team in the Pharma Suite. This opportunity comes with a very competitive salary, bonus, and great benefits!

Job Responsibilities:

• Develop and optimize innovative processes for manufacturing specialized drug delivery products.
• Collaborate closely with R&D, Quality, Operations, Marketing, and Clients to achieve successful project execution.
• Author and execute experimental and validation protocols in chemical processing, coating, and slitting/finishing, ensuring adherence to 21CFR211 guidelines.
• Design and conduct experiments, utilizing statistical analysis tools (SPC, ANOVA, Regression, etc.) for data interpretation and decision-making.
• Generate essential design documentation to support product development and commercialization.
• Utilize software tools for communication, project tracking, engineering analysis, and statistical modeling (e.g., Excel, PowerPoint, Project Management, DOE tools).
• Provide clear and effective communication with cross-functional teams, including Engineers, Scientists, Supervisors, and Customer Logistics Coordinators.
• Lead problem-solving initiatives and implement changes following change control procedures.
• Enhance and share expertise in core process technologies, supporting knowledge development within the team.
• Drive innovation in product and process technologies, influencing both divisional and corporate business strategies.
• Ensure all activities are performed in a safe, responsible, and regulatory-compliant manner.

Qualifications:

• Bachelor's degree in Engineering (Chemical Engineering preferred)
• Minimum of five (3) years of experience in a cGMP manufacturing environment.
• Experience in supervisory roles, with a preference for manufacturing supervision.
• Strong expertise in engineering principles, process optimization, and root cause analysis.
• In-depth knowledge of mixing, coating, and finishing process technologies.
• Proficiency in Lean manufacturing, design control, cGMP compliance, FDA regulations, cleaning validation, process validation, DOE, statistical analysis, Quality-By-Design (QBD), and Process Analytical Technology (PAT).
• Familiarity with regulatory filings, including Chemistry, Manufacturing, and Controls (CMC).
• Flexibility to work extended hours or different shifts as needed; willingness to travel (<25%).