Principal Process Engineer

Job Description

Principal Process Engineer

Responsibilities:

• Participate as a team member in high performing cross-functional teams and timely execution of work assignments
• Must possess tactical capabilities in organizing required tasks in executing complex project work
• Must exhibit customer focus and effectively communicate with peer-level partners, user groups, senior management, and clients.
• In depth working knowledge of cGMP requirements for pharmaceutical manufacturing
• Must be compliant with processes, procedures, and instructions for all activities on assigned tasked.
• Participate in process equipment design, build, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), activities including the following: develop capital planning and execution for planned and unplanned process equipment needs, coordinating efforts with end users and equipment fabricators, collaborate, review, and comment on equipment documentation (Design documents, Site Procedures (SOPs), and validation protocols, assist with equipment integration to site network, other systems, and site historian
• Planning site activities with vendors
• Facilitate FMEA and risk assessments on process equipment
• Support the validation team during execution of Installation and Operational Qualification (IQ/OQ) activities.
• Assistance to include onsite support on off hours, nights, weekends, and holidays as needed to support the manufacturing production activities
• Supporting efforts for process equipment located within a cleanroom environment
• Participate in daily huddle meetings as a representative for process equipment
• Support site process improvement initiatives
• Complete investigations of process system deviations and implement corrective and preventive actions as required to mitigate future recurrence
• Manage relevant engineering activities and prioritize work to ensure site and project timelines are met. This will include direct assistance on the production floor.
• Assists in programming, maintenance, and troubleshooting of programmable logic controllers and process and building monitoring systems
• Interface with other departments and sites regarding special projects and quality issues, demonstrating technical proficiency, scientific creativity and collaboration
• May be called upon to speak to regulatory agencies regarding manufacturing systems and equipment as a subject matter expert
• Liaise with quality assurance and regulatory affairs and prepare/review documentation required for regulatory submissions and change controls
• Write and revise SOPs and Master Plans
• Effectively present complex technical information to guide decision making

Requirements:

• Bachelor’s degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines
• Minimum of five years of industry experience
• Minimum 5 years engineering experience in a pharmaceutical industry setting with a focus on aseptic processing and lyophilization
• Extensive knowledge of GMP requirements and regulations
• Ability to effectively communicate, interact, and collaborate with internal and external team members
• Strong analytical skills, hands-on troubleshooting skills and the capability to utilize analysis software and company quality system software