Senior Process Engineer - Large Molecule

Job Description

Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.

Source One is a consulting services company and we're currently looking for the following individual to work as a consultant with our direct client, a global pharmaceutical manufacturing client in Wilson, NC.

No Third-Party, No Corp to Corp, No Sponsorship Now, Future or Temporary Authorization

Senior/Principal Engineer – Large Molecule Drug Substance (LMDS)

Pay Rate: $72.40/hr (w2)

Location: Wilson, NC

Contract: 24 months

Travel: Domestic travel up to 10% (primarily annual project/site support)

Position Summary

We are seeking a senior-level engineering leader to support the design, start-up, and operational readiness of a GMP large molecule biologics manufacturing facility. This role will provide advanced process and manufacturing engineering expertise across equipment, utilities, automation, and facility systems supporting technology transfer, CAPEX projects, and manufacturing start-up activities. The ideal candidate brings deep biologics drug substance experience, proven GMP facility start-up leadership, and the ability to drive complex engineering projects from design through commissioning and operational handoff.

Experience

• Minimum 8+ years of process or plant engineering experience within GMP large molecule biologics manufacturing environments
• Proven experience supporting greenfield and/or brownfield biologics manufacturing facility start-ups
• Strong experience with drug substance manufacturing systems, utilities, automation, and facility integration
• Demonstrated expertise in equipment design, commissioning, FAT/SAT execution, and start-up activities
• Strong technical leadership, analytical problem-solving, and cross-functional collaboration skills
• Deep understanding of GMP regulations, manufacturing operations, and engineering project execution

Top 3 Non-Negotiable Skills

• Large molecule biologics drug substance manufacturing experience
• GMP facility start-up, commissioning, and FAT/SAT leadership
• Process equipment design and integrated manufacturing systems expertise

Key Responsibilities

• Lead engineering design, start-up, commissioning, and operational readiness activities for large molecule biologics manufacturing systems and equipment
• Serve as SME and process systems owner for strategic CAPEX and manufacturing projects
• Provide technical leadership for technology transfer initiatives and implementation of new manufacturing technologies
• Support "right first time" execution by integrating process, equipment, utilities, automation, and facility engineering solutions
• Partner xhyhwjd with external engineering firms, construction teams, and equipment vendors to execute project deliverables, including FAT, SAT, and start-up activities
• Collaborate cross-functionally with Manufacturing, Quality, Engineering, and Technical Operations to align projects with GMP requirements, company standards, and operational goals
• Evaluate manufacturing and technology challenges and develop scalable engineering solutions that support business and operational objectives
• Lead and influence cross-functional teams while managing project risks, technical issues, and execution priorities
• Ensure compliance with GMP regulations, engineering standards, and manufacturing best practices

Education

• Bachelor's degree in Chemical Engineering or Mechanical Engineering required
• Advanced degree (MS, MBA, or PhD) and/or PE certification preferred