Band Grade : 5-C
Annual Wage Range: $77,981.60 - $107,224.70
Other Compensation: Eligibility for the Short-Term Incentive program and other applicable bonuses
Benefits: U.S. Employee Benefits Summary (grace.com)
Job DescriptionDo 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.
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.
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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
