Chemical Process Engineer

Job Description

Do you thrive in a fast-paced, dynamic environment where your process engineering expertise impacts the delivery of life-saving medicines? Imagine collaborating on critical production campaigns for external clients, ensuring flawless execution and navigating complex regulatory landscapes. This is not just a job; it’s a pivotal role at the heart of a global pharmaceutical supply chain.

Grace seeks a motivated Chemical Process Engineer for our state-of-the-art Active Pharmaceutical Ingredient (API) manufacturing facility in South Haven, Michigan. This role offers a unique opportunity to build your expertise in process engineering, regulatory compliance, and validation. You’ll contribute directly to a culture of excellence, ensuring the highest quality and regulatory adherence. We offer a rewarding environment with progressive developmental opportunities to help you broaden your engineering skillset while also honing your specialties. If you have a strong technical background and a commitment to exceptional results in a Current Good Manufacturing Practices (cGMP) environment, we encourage you to apply.

This role is on-site in South Haven, MI and reports to the site engineering organization.

Responsibilities

• Lead engineering programs for Contract Development and Manufacturing Organization (CDMO) production campaigns, collaborating daily with cross-functional groups (Quality, Regulatory, Compliance, Operations, Process Safety, R&D) to ensure seamless execution.
• 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 ensuring first-time right execution.
• Develop and execute validation protocols and summary reports for Phase 3 and commercial API programs.
• Convey engineering information to site management and external partners/customers.
• 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), while ensuring adherence to Management of Change (MOC) processes.

Required Qualifications

• Bachelor’s Degree in Chemical Engineering
• 2+ years experience in a manufacturing or process development environment

Preferred Qualifications

• Batch manufacturing experience in a cGMP environment
• Batch control, process simulation experience
• Industrial experience as an individual contributor and in cross-functional teams, including customer facing role

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Benefits

• 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 Wellness Center