3 Key Consulting, Inc.

Engineer Associate Director – Start-Lead New Drug Substance Facility (JP14556)

3 Key Consulting, Inc.  •  $82 - $92/hr  •  Holly Springs, NC (Onsite)  •  2 months ago
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Job Description

Job Title:   Engineer Associate Director – Start-Up Lead New Drug Substance Facility (JP14556)
Location: Holly Springs, NC. 27540 (REMOTE with up to 25% travel to Holly Springs, NC.
Employment Type: Contract
Business Unit: DST Business Operations
Duration: 9+ months (with likely extensions and/or conversion to permanent)
Posting Date: 09/23/25
Pay Rate: $82 - $92/hour W2 with benefits
Notes: Only qualified candidates need apply. Remote- up to travel 25% to holly springs, NC

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


Candidates will be thoroughly screened for their experience and basic qualifications. We are NOT looking for an SME in a specific area but instead an independent experienced leader who can come into a new and upcoming site with a broad spectrum of knowledge and experience to be utilized amongst site teams

Highly versatile and experienced subject matter expert able to contribute as an individual or to lead teams across a wide range of drug substance technical areas.

  • Responsible for aspects of the successful preparation, strategy, and execution of Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ) during the start-up a of new Drug Substance production facility.
  • Responsible for enabling CMC Regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting.
  • The qualified candidate will lead technical teams across various disciplines and objectives.
  • Additional Responsibilities:
    • Work cross-functionally with individuals and project teams in Process Development, Manufacturing, Quality, and Facilities and Engineering;
    • Create and assess process technical assessments to support deviations and validations;
    • Create and execute to project plans and schedules;
    • Develop, execute, and review technical documents, validation documents, specifications, development plans, characterization plans, and verification and validation plans
    • Provide deep technical assistance for junior engineers.

Why is the Position Open?
Planned project.

Top Must Have Skills:
  • Candidates must have experience and basic qualifications. We are NOT looking for an SME in a specific area but instead an independent experienced leader who can come into a new and upcoming site with a broad spectrum of knowledge and experience to be utilized amongst site teams.
  • **Broad set of expertise** across DS with extensive experience, including:
    • Technology Transfer
    • Process Scale-up
    • Clinical & Commercial Manufacturing Support
    • Process Performance Qualification (PPQ)
    • CMC Regulatory file drafting and support
    • Commissioning and qualification of equipment
    • Utilization of process models
    • Process characterization, and process optimizations and troubleshooting.
(Essentially someone at Principal Engineer or Director level in their current role)
  • Strong technical and management skills, will need to deliver as an individual and team lead
  • Strong collaborations skills, track record of team environment success

Day to Day Responsibilities:
Lead or contribute teams in areas above, delivering the required business result.

Basic Qualifications:
Basic Qualifications:
Doctorate degree and 3 years of experience
OR
Master’s degree and 7 years of experience
OR
Bachelor’s degree and 9 years of experience
OR
Associate’s degree and 12 years of experience
OR
High school diploma / GED and 14 years of experience

Employee Value Proposition:
  • Unique industry opportunity
  • Career growth

Red Flags:
  • Highly specialized in one drug substance (DS) area or no DS experience
  • No management experience
  • No experience supporting Manufacturing

Interview process:

Phone screen by EWC, Phone 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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