Engineer Associate Director – Start-Lead New Drug Substance Facility (JP14556)
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Job Location:
Holly Springs, MS - USA
Hourly Salary:
$ 82 - 92
Posted on:
25-09-2025
Vacancies:
1 Vacancy
Job Summary
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.
Why is the Position Open
Planned project.
Top Must Have Skills:
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
Masters degree and 7 years of experience
OR
Bachelors degree and 9 years of experience
OR
Associates degree and 12 years of experience
OR
High school diploma / GED and 14 years of experience
Employee Value Proposition:
Red Flags:
Interview process:
Phone screen by EWC Phone interview with hiring manager
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
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.
- 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
Masters degree and 7 years of experience
OR
Bachelors degree and 9 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
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 sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
Director
Key Skills
- Data Center Experience
- Facilities Maintenance
- Maximo
- Facilities Management
- HVAC
- Mechanical Knowledge
- CMMS
- OSHA
- Maintenance
- Mechanical Engineering
- Microsoft Project
- QA/QC
