NNE · 1 day ago
Lead Process Engineer - Clayton NC
Clayton, NC
Full-time
Onsite
Senior Level, Lead/Staff
7+ years expNNE is a global engineering design firm specializing in the pharmaceutical space, and they are seeking a Lead Process Engineer to drive innovation in pharmaceutical design while leading impactful onsite projects. This role emphasizes efficiency, problem-solving, and teamwork, bridging client needs with technical execution to deliver high-quality solutions.
Innovation ManagementPharmaceuticalProfessional Services
No H1B
Responsibilities
Translate user requirements into clear design criteria
Direct the engineering team through deliverables
Guide other discipline leads for cohesive results
Oversee design elements: mass/energy balances, P&IDs, calculations, datasheets, equipment lists, instrument and component lists, line lists, layout drawings, and 3D models
Manage client stakeholder relationships
Partner with the Project Manager on risks, scope, priorities, and strategies
Support on-site activities: as-builts, startup, commissioning, and qualification
Qualification
Required
Bachelor or Master degree in Engineering or a related technical field
At least 7 years of experience in regulated industries (e.g., pharma, biotech)
Experience leading technical teams and complex design projects
Strong knowledge of industry standards, project lifecycles, and design documentation
Solid analytical skills for adapting policies and procedures
Willingness to work in Clayton in a fast-paced, project-driven environment
P.E. Licensure is a plus
Work Authorization Requirement: Applicants must be legally authorized to work in the United States for any employer. We do not provide visa sponsorship or assume sponsorship for employment visas
Preferred
Familiarity with ASME BPE standards for bioprocessing equipment design and sanitation
In-depth knowledge of cGMP guidelines and FDA regulations for pharmaceutical manufacturing compliance
Understanding of ASME codes for pressure vessels, piping, and mechanical systems in pharma facilities
Knowledge of NFPA standards for fire protection and hazardous materials handling in industrial settings
Proficiency with NEC for electrical system design and safety in pharmaceutical environments
Proficiency in process simulation and modeling software (e.g., Aspen Plus or SuperPro Designer)
Experience with validation protocols, including IQ/OQ/PQ for equipment qualification
Working knowledge of USP (United States Pharmacopeia) and EP (European Pharmacopoeia) standards for materials and testing
Strong vendor coordination skills for sourcing compliant equipment and solutions
Benefits
160 hours of PTO (prorated from hire date) + 14 paid holidays.
Health, dental, and vision insurance from day one.
8% guaranteed 401(k) contribution.
14 weeks paid parental leave.
Company-paid life and disability insurance.
Employee referral bonuses.
Company
NNE
NNE is a pharma engineering company.
1001-5000 employees
Funding
Current Stage
Late StageRecent News
madisonstartups.com
2022-08-19
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