Specialist, Engineering
Merck · Durham (old Oxford), NC
CMCFull-time$87k–$137kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Merck seeks an Engineering Specialist at its Durham vaccine manufacturing facility to lead technology transfer, process improvements, and regulatory compliance for vaccine drug substance and manufacturing support programs. The role requires technical expertise in biologics manufacturing, cross-functional collaboration, and post-approval operational support.
What they're looking for
- Bachelor's degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field plus two years relevant experience, or Master's degree
- Experience in vaccine or biologics manufacturing within cGMP environment
- Demonstrated ability authoring technical documentation in cGMP context
- Strong leadership with excellent written and presentation communication skills
- Experience in project strategic planning and management
- Ability to develop collaborative work environment with mentorship focus
What you'll be doing
- Lead technical support and team guidance for commercial technology transfer and qualification studies for vaccine processes and systems
- Participate in cross-functional manufacturing teams to advance project goals and deliverables
- Provide subject matter expertise for manufacturing investigations related to product, process deviations, and complex material issues
- Author, review, and manage change control documentation for process, validation, equipment, and facility modifications
- Present and defend technical documentation during regulatory inspections and lead aspects of compliance activities
Privacy & handoff
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