Engineer Associate Director - Start-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.
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.
- Strong technical and management skills, will need to deliver as an individual and team lead
- Strong collaborations skills, track record of team environment success
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
- Highly specialized in one drug substance (DS) area or no DS experience
- No management experience
- No experience supporting Manufacturing
Phone screen by EWC, Phone 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 You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
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