Process engineer

Job Title: Process Engineer Location: Raleigh, NC (Onsite) Job Type: Contract Industry: Biopharmaceutical / Pharmaceutical

Job Summary:

We're hiring a Process Engineer to support pharmaceutical and biopharmaceutical facility projects in the Research Triangle Park (RTP) area. This role involves process design, equipment specification, utility coordination, and hands-on support for FAT, SAT, commissioning, and automation phases.

Key Responsibilities:

Lead or support the design and specification of cGMP equipment, clean utilities, and process systems

Generate and review engineering documentation: PFDs, P&IDs, GAs, floor and piping plans, and shop drawings

Perform equipment and utility sizing calculations (tanks, pumps, filters, pressure drops, consumptions)

Prepare and review technical documentation: URS, FRS, SDS, and equipment data sheets

Liaise directly with client end-users to ensure accurate and complete specifications

Conduct assessments (CIP skid capacity, hydraulics, instrument and valve lists, etc.)

Translate process requirements into automation specs and participate in FAT/SAT

Support commissioning, cleaning cycle development, and spray coverage testing

Work with stainless steel process systems and clean utilities per ASME BPE standards

Participate in large-scale powder handling, mixing operations, and equipment start-up

Required Qualifications:

Bachelor’s degree or higher in Chemical or Mechanical Engineering

10+ years of experience in the biopharmaceutical industry

Strong background in cGMP manufacturing environments

Proficiency in process engineering documentation and mechanical design

Familiarity with ASME BPE and FDA validation expectations

Skilled in startup and commissioning of pharma equipment

Able to read and interpret automation documentation and translate process logic