Jobs at Grand River Aseptic Manufacturing, Inc.

Owns and supports quality systems for a quality control analytical laboratory, including CAPA, investigations, deviations, change controls, OOS processes, training, LIMS administration, equipment lifecycle management, and laboratory projects. Serves as a QC subject matter expert, leads cross-functional deliverables, troubleshoots instruments and software methods, manages vendors, and mentors laboratory personnel.

Supports business operations by translating demand forecasts into production and operational plans. Maintains planning tools, operational data, dashboards, and performance metrics; tracks production schedules, batch releases, customer commitments, and action items. Coordinates cross-functional meetings, prepares reports and presentations, identifies scheduling conflicts and operational risks, and escalates issues to support timely execution, revenue realization, and customer delivery.

Lead GRAM’s Quality Systems while overseeing aseptic manufacturing operations. Responsibilities include managing quality teams, authoring and reviewing cGMP documentation, investigating nonconformances, interpreting regulatory standards, supporting regulatory interactions, allocating resources, and driving continuous improvement in a regulated pharmaceutical manufacturing environment.

Drives new business growth and account penetration within the pharmaceutical parenteral and contract manufacturing market. Manages territories, prospects, sales pipelines, proposals, negotiations, forecasts, and key customer relationships. Uses consultative selling to close business, improve client satisfaction, and communicate customer needs internally. May supervise and mentor business development staff while ensuring compliance with cGMP training and company requirements.

Lead end-to-end technology transfer, commercial supply, and lifecycle management projects in a sterile pharmaceutical manufacturing environment. Manage scope, schedules, milestones, risks, change controls, documentation, resources, and issue resolution. Serve as the primary customer liaison, coordinate cross-functional teams, oversee contractual commitments, provide leadership updates, facilitate meetings, and strengthen client relationships. The role is fully onsite and supports customer visits.

Supervise QC microbiology activities supporting aseptic manufacturing, including routine, in-process, stability, and finished-product testing; environmental monitoring; critical utility monitoring; training; equipment calibration; investigations; CAPAs; documentation; method and SOP authoring; data trending; vendor coordination; and audit support. Serve as a microbiology subject matter expert during client and regulatory audits while ensuring compliance, accurate records, and continuous improvement.

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.

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.

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.