Lead Process Engineer - Clayton NC

NNE•Clayton, NC

1d•Onsite

About The Position

Drive innovation in pharmaceutical design while leading impactful onsite projects. As a Lead Process Engineer at NNE, you’ll bridge client needs with technical execution—delivering practical solutions, fostering collaboration, and ensuring compliance. This hands-on leadership role emphasizes efficiency, problem-solving, and teamwork. NNE is a global engineering design firm specializing in the pharmaceutical space. Our U.S. office is embedded onsite with Novo Nordisk, giving you direct access to one of the largest pharmaceutical manufacturing facilities in the state. This unique setup combines the precision of a design firm with real-time involvement in upstream and downstream processing, fill-finish, packaging, and oral solid dosage (OSD) projects—where practical solutions come to life. Primary Duties and Responsibilities: As a Lead Process Engineer, you’ll play a critical role in driving project success for pharmaceutical equipment design initiatives. Leveraging your technical expertise, you will lead a team of process engineers and collaborate closely with other discipline leads to deliver high-quality solutions. This position reports to the Design Department Manager. Through our partnership with Novo Nordisk, we manage a diverse portfolio of capital projects. When challenges arise beyond standard work, you’ll provide problem-solving expertise and conduct detailed studies to ensure optimal outcomes. What You’ll Do 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. 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.

Requirements

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.
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.

Nice To Haves

P.E. Licensure is a plus.
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.

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.