Process Engineer

Job Title: Process Engineer

Location: Raleigh, NC (Onsite)

Experience: 10+ Years

Duration: 12+ Months

Overview

We are seeking an experienced Process Engineer to provide site-based support for pharmaceutical and biopharmaceutical clients in the RTP area. This role involves contributing to conceptual, basis, and detailed design of production facilities, while supporting FATs, SATs, commissioning, automation, and project management activities.

Key Responsibilities

Support and lead the design and specification of cGMP equipment, processes, and utilities.

Develop, review, and redline project documentation, including circuits and flow paths.

Perform engineering assessments such as CIP skid capacity, preliminary hydraulics, new equipment sizing, line sizing, valve lists, and instrument lists.

Liaise with client end-user groups to define correct specifications for equipment and utilities.

Prepare technical and functional specifications for automated and manual equipment.

Support FAT and SAT execution, commissioning, and startup activities.

Conduct spray coverage testing, cleaning cycle development, optimization, and troubleshooting.

Required Skills and Experience

BS or higher in Chemical or Mechanical Engineering.

10+ years of experience in the biopharmaceutical industry.

Strong expertise with engineering drawings and documentation, including:

Process Flow Diagrams (PFDs)

Piping & Instrumentation Diagrams (P&IDs)

General Arrangements (GAs), floor plans, piping plans

Vendor mechanical shop drawings

Equipment data sheets, valve & instrument lists

Proficiency in engineering calculations:

Equipment sizing (tanks, pumps, filters, etc.)

Piping and valve sizing for pressure drop

Utility consumption calculations

Hands-on experience with specifications:

User Requirement Specs (URS)

Functional Requirement Specs (FRS)

Software Design Specs (SDS)

Familiarity with automation documentation and ability to translate process data into automation requirements.

Strong knowledge of clean utilities and stainless-steel process equipment design.

Experience with large-scale powder charging and buffer mixing operations (SS tanks, mixers, material lifts).

Working knowledge of ASME BPE standards.

Proven track record with startup and commissioning activities.