API Process Engineer - On-Site, cGMP

W. R. Grace; South Haven (MI); On-site; USD 78,000 - 107,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

Life Insurance and Disability

Grace Wellness Program

Flexible Workplace

Retirement Plans

401(k) Company Match

Paid Vacation and Holidays

Parental Leave

Tuition Reimbursement

Company Donation Match Program

Site specific contribution to local

Job summary

Grace, a leading global pharmaceutical supplier, seeks a Chemical Process Engineer for our on-site API manufacturing facility in South Haven, Michigan. You will apply process engineering expertise to support production campaigns, ensure regulatory compliance, and drive improvements in a cGMP environment.

You will lead cross-functional efforts with Quality, Regulatory, and Operations, develop validation protocols, author batch records, and contribute to continuous improvement initiatives.

Qualifications

• Bachelor’s degree in Chemical Engineering required.
• Strong understanding of chemical process fundamentals and unit operations.
• Strong written and verbal communication skills.

Responsibilities

• Lead CDMO production campaigns with cross‑functional teams to ensure seamless execution.
• Identify and resolve production issues ensuring compliant operations.
• Navigate API development and author Deviation/Investigative reports.
• Convey engineering information to site management and external partners.
• Author cGMP batch records ensuring first‑time right execution.
• Develop and execute validation protocols and summary reports for Phase 3 and commercial APIs.
• Evaluate process performance and propose improvements with technical reports.
• Drive continuous improvement across the plant while adhering to MOC processes.

Skills

Strong understanding of chemical

Strong written and verbal comms

Education

Bachelor’s Degree in Chemical Engineering

Job description

Grace, a leading global pharmaceutical supplier, seeks a Chemical Process Engineer for our on-site API manufacturing facility in South Haven, Michigan. You will apply process engineering expertise to support production campaigns, ensure regulatory compliance, and drive improvements in a cGMP environment.

You will lead cross-functional efforts with Quality, Regulatory, and Operations, develop validation protocols, author batch records, and contribute to continuous improvement initiatives.