3 Key Consulting, Inc.

Engineer Principal – Drug Substance Manufacturing Process Optimization & Tech Transfer (REMOTE) (JP14711)

3 Key Consulting, Inc.  •  $55 - $62/hr  •  Holly Springs, NC (Remote)  •  1 month ago
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Job Description

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.


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  resumes@3keyconsulting.com  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.

3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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