Global Process Engineer (Aseptic)
AbbVie · Durham, NC
- Level
- Engineer
- Team
- Process
- Experience asked
- 8+ years
- Industry
- Pharma & life sciences
- Posted
- 8 days ago
The role in 30 seconds
An engineer-level process role at AbbVie (pharma & life sciences) in Durham, NC.
- They ask for
- 8+ years
- Tools it names
- FMEA, Robotics, MES
Read from the posting. The full description is below.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Process team at AbbVie
We found 1 person at this company and state: 1 on the team. Engineers who joined in the last year or two reply the most. See them ↓
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
Write to Diem → (free) - 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Is the work mostly new product launches or sustaining existing lines?
- How much time do you spend on the floor versus at a desk?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
About the role
Responsibilities
- ◆Serves as organization spokesperson on advanced projects and/or programs related to aseptic operation including equipment selection. Presents results of projects both internally and externally.
- ◆Acts as advisor to management and operating sites on applications of new advanced processing equipment and participates in project planning, process update
- ◆Responsible for timely project completion.
- ◆May act as lead engineer, project leader, or project contributor.
- ◆Ensures quality and effectiveness of aseptic solutions as part of major projects through sound design, early risk assessments, and implementation strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes.
- ◆Evaluates and integrate relevant engineering advances for improving or solving problems.
- ◆Understands the business implications of assigned products and processes and identify engineering solutions compatible with business needs.
- ◆Provides technical direction and feedback to others.
- ◆Responsible for compliance with applicable corporate and local policies and procedures.
MS or PHD in Mechanical, Chemical Engineering or related field with 6 to 8 years of engineering experience in pharmaceutical aseptic process design, equipment selection and operation in one of the following areas:
- ◆general aseptic processing;
- ◆upstream and downstream biological processing;
- ◆aseptic fill finishing
requirements
both in Europe and the US
- ✓Methods of Microbial control and environmental monitoring
- ✓Control and information systems used in secondary pharma and fill finish on particular
- ✓Understands both equipment control and SCADA and MES levels.
- ✓Secondary packaging
- ✓Single use systems
- ✓Cleaning and sanitisation methodologies.
- ✓Knowledge about associated technology (Lyophilisation, Blow Fill Seal)
- ✓Application of robotics
requirements
- ✓key literature beyond regulations (ISPE, AMSE, ISO, USP)
- ✓project costing, lead times, control and management
- ✓broader commercial environment in the Pharma industry.
Experience
- ✓Demonstrated excellence in breadth and depth of knowledge within the aseptic discipline and is recognized as a subject matter expert
- ✓Experience active participating or leading FMEA, Risk Assessments and/or Investigations for aseptic pharmaceutical processes.
- ✓Must demonstrate negotiation skills and ability to reconcile differences
Show full description ↓Show less ↑
Purpose
The Global Process Support Engineer (Aseptic) will support the AbbVie Technical Operations Functions and the AbbVie Technical Centers worldwide. This position will be responsible for applying advanced scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete complex assignments related to aseptic capital projects and aseptic process troubleshooting. The selected candidate will contribute to the development of new principles and concepts and is expected to lead change from an engineering perspective. Will also be responsible for solving operating issues and providing technical support to cross-functional teams within the Aseptic sites.
Good knowledge of
- •Aseptic fill finish technology and suppliers
- •Broader compounding, built infrastructure (cleanroom design, services (water, HVAC…..)
- •Knowledge of regulatory environment and
Understanding of
- •typical process analysis and troubleshooting tools.
- •high containment processing
- •change control