Engineer Principal - Drug Substance Manufacturing Process Optimization & Tech Transfer (REMOTE) (JP1

Job Title: Engineer Principal – Drug Substance Manufacturing Process Optimization & Tech Transfer REMOTE (JP14711) Location: Holly Springs, NC. 27540 (Remote but all job seekers need to commit to two weeks on-site during critical operations and should be local/ willing to travel to Holly Springs, NC. Campus) Employment Type: Contract Business Unit: Drug Substance Technology Business Operations Duration: 6+ months (with likely extensions and/or conversion to permanent) Posting Date: 10/28/25 Pay Rate: $55 - $62/hour W2 Notes: Only qualified candidates need apply. Remote but all job seekers need to commit to two weeks on-site during critical operations and should be local/ willing to travel to Holly Springs, NC. Campus 3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. Job Description: Remote but all job seekers need to commit to two weeks on-site during critical operations and should be local/ willing to travel to ANC campus Lead optimization of drug substance processes related to pharmaceutical manufacturing technology transfer. Lead sub-teams and provide expertise to support drug substance manufacturing. Provide support for technical troubleshooting in a GMP environment, investigations, and deviation/CAPA strategy. Candidate should be proficient in process monitoring tools, data visualization tools (e.g., Spotfire), and GMP principles. Candidate needs to travel periodically to the manufacturing site for critical activities. Candidate will need to provide second shift process monitoring as needed.

• Provide technical leadership for cross functional project teams working on complex business challenges, communication of work through presentations, and authorship and review of documentation.
• The candidate will be expected to keep current on the latest industrial, scientific, business, and regulatory trends.
• Build and maintain effective collaborations with partner organizations across client’s Process Development and Operations Networks.

Why is the Position Open? Supplement additional workload on team Top Must Have Skills:

• Proficient in tech transfer
• Proficient in MFG Support
• Able to lead sub-teams and provide expertise for technical troubleshooting

Day to Day Responsibilities:

• Lead optimization of drug substance processes related to pharmaceutical manufacturing technology transfer.
• Lead sub-teams and provide expertise to support drug substance manufacturing.
• Provide support for technical troubleshooting in a GMP environment, investigations, and deviation/CAPA strategy.
• Candidate should be proficient in process monitoring tools, data visualization tools (e.g., Spotfire), and GMP principles.
• Candidate needs to travel periodically to the manufacturing site for critical activities.
• Candidate will need to provide second shift process monitoring as needed.

Basic Qualifications: Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience Employee Value Proposition:

• Unique industry opportunity
• Career growth
• Networking

Red Flags:

• Lab experience only
• Unwilling to travel
• Unwilling to work outside day shift

Interview process: Video conference interview with hiring manager We invite qualified candidates to send your resume to [email protected]. 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 www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Apply tot his job Apply To this Job