Regulated Manufacturing Project Engineer – cGMP Focus

Salas O'Brien; Raleigh (NC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off and company holidays

Wellness programs

Job summary

Salas O’Brien in Raleigh, NC is seeking a Project Engineer to support capital projects in regulated manufacturing environments, including pharmaceutical and life sciences, under cGMP. You will coordinate activities across engineering, operations, quality, validation, and vendors to ensure compliance and timely delivery.

You’ll develop documentation, maintain project records, and communicate risks and progress to stakeholders.

Qualifications

• Bachelor’s degree in Engineering (Chemical, Mechanical, or equivalent preferred).
• Equivalent education and experience may be considered for candidates with significant regulated manufacturing experience.
• 0–5 years of experience in capital projects or project execution, preferably in pharmaceutical, biotech, or life sciences industries.
• Experience coordinating with vendors, contractors, and internal teams to support project implementation.
• Familiarity with change control, validation, and documentation systems in regulated environments.

Responsibilities

• Support and execute capital projects within operating facilities or greenfield projects, including equipment installations, system modifications, expansions, and process improvements.
• Coordinate project activities across engineering, operations, quality, validation, and vendor teams to ensure alignment with technical, schedule, and compliance requirements.
• Develop and manage documentation including meeting notes, action tracking, and project deliverables.
• Support implementation of projects in environments requiring change control, validation, and controlled documentation practices.
• Communicate effectively with clients, contractors, and project teams regarding scope, deliverables, risks, and compliance requirements.

Skills

Capital projects coordination

Cross-functional collaboration

Documentation management

Regulated environments knowledge

Change control

CQV/validation familiarity

Equipment installation

Project scheduling

Vendor coordination

Education

Bachelor’s degree in Engineering

Equivalent education/experience considered

Tools

CMMS

Job description

Salas O’Brien in Raleigh, NC is seeking a Project Engineer to support capital projects in regulated manufacturing environments, including pharmaceutical and life sciences, under cGMP. You will coordinate activities across engineering, operations, quality, validation, and vendors to ensure compliance and timely delivery.

You’ll develop documentation, maintain project records, and communicate risks and progress to stakeholders.