Chemical Process Engineer

About the Role

Grace seeks a motivated Chemical Process Engineer for its Active Pharmaceutical Ingredient (API) manufacturing facility in South Haven, Michigan. This role offers an opportunity to build expertise in process engineering, regulatory compliance, and validation, contributing to a culture of excellence and adherence to Current Good Manufacturing Practices (cGMP). This role is on-site in South Haven, MI and reports to the site engineering organization.

Key Responsibilities

• Lead engineering programs for Contract Development and Manufacturing Organization (CDMO) production campaigns, collaborating with Quality, Regulatory, Compliance, Operations, Process Safety, R&D.
• Identify and resolve production issues, ensuring efficient and compliant operations.
• Navigate API development processes (all clinical phases) and author Deviation/Investigative and Corrective Action Reports.
• Convey engineering information to site management and external partners/customers.
• Author high-quality cGMP batch records.
• Develop and execute validation protocols and summary reports for Phase 3 and commercial API programs.
• Evaluate process performance, recommend improvements, and provide technical reports at campaign completion.
• Drive continuous improvement initiatives across the plant (equipment upgrades, procedural refinements, and project implementation), adhering to Management of Change (MOC) processes.

Requirements & Tech Stack

• Bachelor’s Degree in Chemical Engineering
• Strong understanding of chemical process fundamentals and unit operations.
• Strong written and verbal communication skills.
• Willingness to wear PPE (Personal Protective Equipment) including but not limited to hard hat, protective eyewear, steel-toed boots, hearing protection, Level A suit, full face respirator.

Qualifications

• 2+ years experience in a manufacturing or process development environment (preferred).
• Experience troubleshooting manufacturing processes and implementing process improvements (preferred).
• Demonstrated project management and problem-solving skills (preferred).
• Batch manufacturing experience in a cGMP environment (preferred).
• Batch control, process simulation experience (preferred).
• Industrial experience as an individual contributor and in cross-functional teams, including customer-facing roles (preferred).

Candidates must be authorized to work in the United States without the need for current or future employer-sponsored work authorization. This position is not eligible for visa sponsorship or visa transfer.