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.

Supervise aseptic manufacturing operations in a cGMP sterile filling facility: lead staff, oversee cleanroom operations, ensure documentation and compliance, support continuous improvement, and manage deviations and client communications.

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.

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.

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

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 end-to-end project management for technology transfers, commercial supply, and lifecycle projects in a regulated pharma manufacturing environment. Define scope, schedules, risks, and deliverables; coordinate cross-functional teams; manage change controls and documentation in Smartsheet; liaise with customers; drive issue resolution and provide updates to leadership. Fully onsite role supporting customer visits.

Lead and coach continuous improvement initiatives across manufacturing sites using Lean/Six Sigma and OpEx methodologies. Collect and analyze process and quality data, facilitate Kaizen and root-cause investigations, develop improvement roadmaps, standardize best practices, and manage change controls to enhance safety, productivity, and compliance with cGMP/FDA standards.

The QA Specialist ensures compliance in manufacturing processes, oversees quality systems, performs batch record reviews, and collaborates on quality investigations.

The QA Specialist provides quality support for onboarding new clients and ensures compliance with QA principles in a regulated manufacturing environment, including the review of documentation and supporting project timelines.

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.

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