Design - Lead Engineer, Process-SS

Lead Process Engineer

The Lead Process Engineer is responsible for designing and implementing manufacturing processes and supporting utilities on a scale that can range from developmental pilot plant to full commercial production. Ideally, the candidate has process design and operations experience in pharmaceutical facilities, which could include Biologic, Vaccine, API (organic synthesis), oral (OSD) and parenteral (Aseptic) drug products.

Key Activities And Responsibilities

• Produce conceptual design deliverables such as Process Flow Diagrams and Material and Energy Balances.
• Estimate utility requirements for new manufacturing processes, design utilities generation and distribution systems.
• Generate Process P&IDs (preferably on AutoCAD) that include controls strategy and CIP/SIP functions, if appropriate. Also, generate P&IDs for critical utility systems, such as WFI, USP Purified water and Clean Steam.
• Perform engineering studies for expanding, improving or automating existing facilities with limited supervision.
• Produce specifications and performance data sheets for process equipment and instrumentation.
• Make use of and participate in development of company design and production tools, including process simulation and smart P&IDs.
• Assume ownership of the process-related aspects of a portion of a large project or an entire small project, and provide technical support to the design team.
• Establish and maintain excellent working relationships with clients and members of the IPS design team.
• Special projects as assigned.

Qualifications & Requirements

• Minimum of 10 years engineering experience and a minimum of 5 years in process design, preferably in the Pharmaceutical and Biotechnology industries.
• Bachelor's Degree in Chemical Engineering.
• Knowledge of cGMP's as they affect process design and equipment specification.

Context And Environment And Safety

• Travel based on the project location.
• This position is a safety sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research or other "non-administrative" areas.

Demonstrated Competencies

• Must exhibit an entrepreneurial spirit by consistently seeking new opportunities to add value to the organization. Must strive for excellence in all aspects of job performance.
• Must approach their work enthusiastically with a contagious energy and drive that shows everyone they love what they do.
• Must display creativity and innovation by continually working to improve solutions, tools, methods and service delivery system.
• Must conduct oneself with an uncompromising commitment to the welfare of our clients and each other. Must act in an ethical, professional and respectful manner at all times.
• Must exhibit the ability to build and sustain long term relationships of mutual value through teamwork.
• Must be driven to succeed and committed to goal attainment.