Engineer Associate Director – Start-Lead New Drug Substance Facility (JP14556)
Company: 3 Key Consulting
Location: Holly Springs
Posted on: April 1, 2026
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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. Job
Description: 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. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Winston-Salem , Engineer Associate Director – Start-Lead New Drug Substance Facility (JP14556), Healthcare , Holly Springs, North Carolina
