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

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: ContractBusiness Unit: DST Business OperationsDuration: 9+ months (with likely extensions and/or conversion to permanent)Posting Date: 09/23/25Pay Rate: $82 - $92/hour W2 with benefitsNotes: Only qualified candidates need apply. Remote- up to travel 25% to holly springs, NC3 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 teamsHighly 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 experienceORMaster’s degree and 7 years of experienceORBachelor’s degree and 9 years of experienceORAssociate’s degree and 12 years of experienceORHigh school diploma / GED and 14 years of experienceEmployee 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 managerWe 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.