Jobs at Grand River Aseptic Manufacturing, Inc.

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.

Lead supplier quality management and quality system initiatives for GMP manufacturing. Own eQMS processes, conduct third-party audits, manage quality agreements, monitor metrics and trends, drive corrective actions and continuous improvement, support change control and cross-functional troubleshooting. On-site role with ~40% travel for external audits.

Support supplier and incoming material quality, perform quality release of materials, assist supplier qualification and investigations, maintain quality records, support audits, participate in root cause analyses and continuous improvement, and provide on-call quality support within a cGMP pharmaceutical manufacturing environment.

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.