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.
• 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.

Physical Requirements and Environment

Must be willing 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.

Required Qualifications

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

Preferred Qualifications

• 2+ years experience in a manufacturing or process development environment.
• Experience troubleshooting manufacturing processes and implementing process improvements.
• Demonstrated project management and problem-solving skills.
• 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.

To be considered for this position, 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.

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.

Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.