Engineering Consultant

Overview

1400 Perimeter Park Dr, Morrisville, NC 27560, USA

Engineering Consultant role within Sequence, LLC, supporting Southeast Operations with projects primarily in the pharmaceutical/biotechnology industries. The position involves engineering efforts for design and testing of automated systems, including laboratory instrumentation, manufacturing and utilities equipment, and stand-alone computerized systems. The role offers exposure to Pharma 4.0 transformations and implementations and aligns with Sequence’s core values of selfless attitude, continual learning, and initiative.

• Creation and modification of design documentation including user requirements specifications (URS), functional requirement specifications (FRS), and detailed design documentation
• Creation and participation in system classification, system risk assessment, Data Integrity assessments, and vendor assessments
• Participate in and document design review and design qualification activities
• Draft and execute startup test plans to identify and troubleshoot mechanical, electrical, automation, and/or process issues
• Draft and execute commissioning and qualification protocols to demonstrate the process is designed and fit for the intended use
• Occasionally work alongside the training team to onboard and train new employees and assist with client training as needed
• Perform other related duties as assigned

• Bachelor's Degree in Engineering
• 0-3 years of relevant experience
• Strong technical writing skills and proficient use of MS Word, Excel, Visio, PowerPoint, and Project
• Excellent communication and organizational skills
• Ability to develop and manage client relationships
• A willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks

• Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries
• Understanding of business and manufacturing processes as applicable to manufacturing sciences
• Understanding of GxP, GAMP, CFRs (Part 11, 210, and 211)
• Understanding of how to apply SOPs, work instructions, and regulatory requirements
• Technical background encompassing process and automation with the ability to identify issues regarding process and/or automation

• Competitive Pay as a Full-Time Employee
• A 4-week Training Program with ongoing training thereafter
• Generous PTO/Time off
• Bonus Plan
• Reimbursable Expenses
• Medical, Dental, and Vision Insurance
• Employer-paid long-term disability and short-term disability
• A $50,000 team member only life insurance & ADD policy
• 401k plan with employer contributions

Sequence Inc. is an engineering consulting firm specializing in ensuring that facilities and manufacturing processes are designed and tested to meet end-user requirements. Our services span across the manufacturing and construction lifecycle for greenfield and brownfield sites in facilities, utilities, equipment, lab, and computerized systems.

Our employees embody core values that strengthen our culture and guide our success. We value a selfless attitude, continuous learning, and initiative, and we strive to create a respectful environment where ideas are shared and valued.

Sequence Inc. is an Equal Employment Opportunity employer (EOE/M/F/D/V) and prohibits discrimination and harassment of any type. We encourage applicants of all backgrounds and experiences.

This description reflects the current responsibilities and requirements of the role and is subject to change without notice.