Weekend Manufacturing Process Engineer – Aseptic Fill/Finish

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); Vor Ort; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Benefits starting day 1

Paid volunteerism

Zusammenfassung

Grand River Aseptic Manufacturing (GRAM) is seeking a Manufacturing Process Engineer to support weekend operations within a GMP-formulated facility. You will contribute to formulation/fill processes, change controls, and QA collaborations while ensuring safety and compliance.

The role requires a mechanical/engineering background with experience in aseptic processes, cGMP, and on-call availability. Flexible weekend coverage is essential to keep production running smoothly.

Qualifikationen

• Bachelor’s degree in mechanical or electrical engineering, automation, or life sciences OR equivalent work experience.
• Master’s degree with 1 year of relevant experience or Bachelor’s degree with 2 years of relevant experience or 7 years of relevant training and/or experience.
• Proficient computer skills in Microsoft Word, Excel and Outlook.
• Available for off-shift and/or on-call work, as needed.

Aufgaben

• Execute actions from Change Control and CA/PA projects for the manufacturing/finishing department.
• Assess, evaluate, and provide corrective actions for cGMP discrepancies.
• Assist with batch process data, analyze data set, and generate applicable report.
• Develop expertise to ensure equipment in functional area is maintained and operational.
• Work hands on with advanced aseptic fill/finish technologies with some flexibility for on-site support during critical operations.
• Execute minor preventative maintenance (PM) activities.
• Provide support for more advanced PMs executed by the maintenance department and outside vendors.
• Participate in process optimization and troubleshooting efforts for production equipment and software.
• Communicate with leadership on solutions that minimize human error, mechanical failure, environmental contamination, and procedural deviation.
• Support process and plant improvements to increase efficiency and manage costs.
• Update SOPs and forms to improve processes.
• Effectively collaborate with manufacturing, quality assurance, facility engineers, MSAT, microbiologists, project managers, and senior management team.
• Provide guidance to facility engineering and validation during upgrades of clean room spaces and utilities.
• Take corrective action by thinking creatively, solving problems, and develop innovative solutions based on sound science and engineering analysis.
• Execute assignments as directed to support multi-shift operations, training, and testing.

Kenntnisse

Off-shift/on-call availability

MS Word

MS Excel

MS Outlook

Ausbildung

Bachelor’s degree in mechanical or electrical engineering, automation, or life sciences

Master’s degree with 1 year of relevant experience or Bachelor’s degree with 2 years or 7 years training/experience

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Jobbeschreibung

Grand River Aseptic Manufacturing (GRAM) is seeking a Manufacturing Process Engineer to support weekend operations within a GMP-formulated facility. You will contribute to formulation/fill processes, change controls, and QA collaborations while ensuring safety and compliance.

The role requires a mechanical/engineering background with experience in aseptic processes, cGMP, and on-call availability. Flexible weekend coverage is essential to keep production running smoothly.