Engineer – Biologics Drug Substance PPQ ; JP

Overview

Job Title:

Engineer – Biologics Drug Substance PPQ support (JP14922)

Location:

Holly Springs, NC 27540

Employment Type:

Contract

Business Unit: ANC PD Site Lead

Duration: 1+ year with likely extensions and/or conversion to permanent

Posting Date: 1/22/2026

Pay Rate: $34 - $38/hour W2

Notes:
Hybrid onsite 3-5 days onsite. Standard hours

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: B.S and 1-3 YOE, M.S. with some experience is ideal. Nice to have:
Chemical engineering or bioprocessing experience. Process validation or development experience. Technical platforms:
Spotfire, Excel, Smartsheet.

Job Details:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for process validation scope. Employ basic engineering/validation skills and practices to gather process validation acceptance criteria, process parameter data, and performance indicator data to support PPQ campaigns.

Assist with process validation documentation by documentation reviews and data verification of protocols and reports. Perform process validation floor support as needed for sample management verification. Assist in developing sample packages to support MFG, validation datasheets, raw material inventory for studies, and supporting supply chain needs for validation activities

Skills: Worked in a process validation team or process development team for drug substance biologics.

Why is the Position Open? Supplement additional workload on team.

Top Must Have

Skills:

Experience with excel, data verifying, and documentation experience.

Day to Day Responsibilities:

• Support process validation team in the initiation, design, and delivery of projects, particularly for process validation scope.
• Assist with gathering process validation data, data verifying protocols/reports, and double-checking sample collection

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags: Non-scientific background. Frequent job changes

Interview process:

Initial 1on1 with manager, 2nd round panel style interview

We invite qualified candidates to send your resume to  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website  You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.