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