Sr. Process Engineer (SME)

Job Description

Job Description

Title: Sr. Process Engineer SME – Biologics/API
Location: North Chicago IL.
Hire Type: Contract
Shift: 1st Standard business hours
Compensation:70-80/hr

Benefits:

As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.

Must Have Skill Set:
10+ years of process engineering experience in pharmaceutical, biologics, biotech, or API manufacturing environments
Strong GMP manufacturing process knowledge
Experience supporting capital projects and process improvements
Process engineering SME / technical leadership experience
Strong cross-functional communication and stakeholder management skills
Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related technical discipline

Overview:
We are seeking a Senior Process Engineer SME to provide technical process engineering leadership across biologics and pharmaceutical manufacturing projects. This individual will serve as the primary process subject matter expert, supporting engineering teams, project managers, manufacturing operations, and technical stakeholders throughout the project lifecycle. The role is focused on providing technical guidance and manufacturing process expertise for capital projects, process improvements, facility expansions, equipment implementation, and operational readiness activities within GMP-regulated environments.

Job Duties:
Provide technical leadership and process engineering expertise across multiple manufacturing projects and initiatives
Serve as the primary process engineering SME supporting biologics and/or API manufacturing operations
Support process design reviews, equipment selection, and manufacturing strategy discussions
Collaborate cross-functionally with project management, operations, quality, validation, automation, and engineering teams
Review and support process flow diagrams (PFDs), P&IDs, equipment layouts, and utility integration plans
Support manufacturing process optimization, troubleshooting, and risk mitigation activities
Participate in commissioning, startup, and operational readiness activities as needed
Ensure compliance with GMP standards, process requirements, and manufacturing best practices
Provide technical guidance during process changes, facility expansions, and technology transfer activities
Support communication between technical teams and project execution stakeholders
Identify and help resolve process-related project risks and execution challenges
Qualifications:

Required Qualifications:
Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related technical discipline
10+ years of experience in pharmaceutical, biologics, biotech, or API manufacturing environments
Strong understanding of pharmaceutical manufacturing processes and GMP operations
Experience supporting capital projects and manufacturing process improvement initiatives
Ability to provide technical leadership across engineering, operations, and project teams
Strong communication, stakeholder management, and technical leadership skills

Preferred Qualifications:
Experience supporting biologics manufacturing, including upstream/downstream processing, fermentation, or purification systems
Experience with large-scale pharmaceutical manufacturing projects or facility expansions
Knowledge of commissioning, qualification, startup, and manufacturing readiness activities
Familiarity with process equipment, utilities, automation, and manufacturing systems integration
Previous experience acting as a process SME or technical lead on complex manufacturing projects

Equal Opportunity Employer Statement:
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national