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NNE Inc.

Lead Process Engineer

NNE Inc., Clayton, North Carolina, United States, 27520

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Drive Innovation in Pharma Design – Lead Onsite Projects with Impactful Clients: NNE is a global engineering design firm specializing in the pharmaceutical space. Our U.S. office is strategically located on site with Novo Nordisk, enabling seamless collaboration and direct access to projects without leaving the office. This setup combines the precision of a design firm with hands‑on involvement in one of the largest pharmaceutical manufacturing facilities in the state. Our expertise spans upstream and downstream processing, fill‑finish, packaging, and oral solid dosage (OSD) facilities – where practical solutions come to life.

Primary Duties and Responsibilities About the job: This role supports project success in pharmaceutical equipment design initiatives. Drawing on strong technical knowledge and experience, the Lead directs a team of process engineers and provides essential input to other discipline leads. As the technical lead, you’ll manage client stakeholder relationships and work closely with the Project Manager to address risks, scope changes, priorities, and execution strategies.

Through our partnership with Novo Nordisk, we deliver a diverse portfolio of capital projects. When challenges arise beyond standard capital work, we provide problem‑solving expertise and conduct detailed studies. This position reports to the Design Department Manager.

Process Workflow Projects typically begin with URS development alongside the client, followed by mass and energy balances to size equipment and streams. You’ll develop P&IDs, create 3D models, and finalize specifications via datasheets. Most projects are on‑site, so you’ll also support construction through as‑builts, startup, commissioning, and qualification.

Key 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.

Core Duties in Pharmaceutical Process Leadership As a Lead Process Engineer at NNE, you’ll connect client needs with technical execution. This includes converting requirements into actionable designs, mentoring teams, and ensuring compliance while fostering collaboration and problem‑solving. The role emphasizes practical solutions and efficient project delivery in a hands‑on environment.

Required Qualifications

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.

Preferred Skills and Experience

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.

What We Offer You

Competitive salary with annual adjustment increases.

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.

Please submit your application online. Please note that we only accept applications submitted via our online system.

Deadline of application is 11/29/2025

Wewill invite to interviews on a running basis.

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