Jobs at Grand River Aseptic Manufacturing, Inc.

Lead end-to-end technology transfer, commercial supply, and lifecycle management projects for sterile pharmaceutical manufacturing. Act as primary customer liaison, define scope and schedules, manage risks and change control, maintain project documentation in SmartSheet, coordinate cross-functional teams, and support customer visits while driving issue resolution and process improvements.

Support GMP manufacturing in a multi-product aseptic fill/finish CMO: troubleshoot and optimize processes, execute change control and CAPA actions, analyze batch data, maintain equipment, update SOPs, assist with PMs and cleanroom/utility upgrades, and collaborate across QA, MSAT, validation, and operations.

Execute technical support for GMP manufacturing operations in a formulation and aseptic fill/fill-finish facility. Responsibilities include change control and corrective-action projects, cGMP discrepancy resolution, batch data analysis, equipment troubleshooting, preventive maintenance, process optimization, SOP updates, cleanroom and utility upgrades, validation support, and collaboration across manufacturing, quality, engineering, microbiology, and project teams. Weekend production coverage, off-shift availability, and occasional on-call support are required.

Manage bi-weekly payroll and benefits administration: process timecards and payroll changes, enroll and support employees in benefits and 401(k), reconcile benefits invoices, maintain HRIS records, assist with leave claims and verifications, provide employee support, and offer administrative HR assistance onsite.

Support and coordinate external tech transfer projects in a pharmaceutical/aseptic manufacturing environment. Create schedules, track risks and action items, manage scope and budgets, liaise with customers, run status meetings, prepare presentations, and escalate issues to ensure timely project delivery.

Perform microbiological testing and environmental monitoring to support aseptic pharmaceutical manufacturing. Duties include utility sampling, bioburden/endotoxin testing, data entry and trending, equipment maintenance, SOP/test method revisions, investigations, training, and GMP-compliant lab documentation and aseptic conduct.

Support and lead environmental monitoring and microbiology testing in an aseptic manufacturing environment. Perform method development/validation, sample receipt, reagent preparation, bioburden/endotoxin testing, growth promotion, isolate identification, data entry/trending, training, documentation, and support audits and CAPA activities while ensuring GMP compliance.

The Director of Manufacturing will oversee production management, continuous improvement, capability building, and people management, ensuring quality and operational excellence in compliance with regulations.

Manage and support new equipment implementation and client manufacturing processes, ensuring compliance with regulations and documentation accuracy.

Oversee quality systems and aseptic manufacturing operations, ensuring compliance with regulations and leading a team to meet quality standards.

Manage and oversee quality systems for cGMP drug manufacturing (NCR, CAPA, Change Control, EV). Lead investigations, facilitate cross-functional teams, implement quality deliverables, own processes, and train staff on root cause analysis and quality system best practices.

Perform aseptic manufacturing tasks per SOPs and cGMP: equipment prep, bulk formulation, aseptic filling, cleaning/sanitization, batch record documentation, and cleanroom gowning. Work in Grade 5/ISO 6/7/8 cleanrooms, complete qualification programs, and follow respirator/PAPR requirements when handling hazardous chemicals. Shift-based role at Butterworth Facility.

The Senior Manufacturing Process Engineer leads process optimization projects, troubleshoots issues, and ensures compliance in pharmaceutical manufacturing. Responsibilities include mentoring staff, managing projects, and implementing new technologies.