Description

　　Quality, Service, Collaboration, Courage.Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.

　　Overview of this Position:

　　The Manufacturing Process Engineer executes technical support activities for GMP Manufacturing Operations in a multi-product, Fill/Finish CMO facility including activities related to compliance, quality, targeted innovation, and plant performance and success. Responsible for the production in one of two functional areas: Aseptic Filling or Formulation/Prep.

　　Non-Negotiable Requirements:

　　Bachelor's degree in mechanical or electrical, engineering, automation, or life sciences OR equivalent training and/or experience is necessary.

　　Three years in a production engineering role, or 3-5 years of relevant experience in pharmaceutical manufacturing or a laboratory environment is required.

　　Available for off-shift and/or on-call work, as needed.

　　Preferred Requirements:

　　Previous experience in a CMO and/or sterile pharmaceutical manufacturing preferred.

　　Responsibilities Include (but are not limited to):

　　Transfer technical processes from the MSAT and validation groups to the production floor with the assistance of the Production Team (Supervisor, Leads, and Trainers). Required to flex schedule to ensure on-site support during execution of critical operations.

　　Assess, evaluate, and provide immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis, and reporting.

　　Develop technical expertise to ensure equipment in functional area is maintained and operational by completing or assisting with the completion of preventative maintenance activities with the maintenance department.

　　Responsible for overseeing and training on the changeover and testing of equipment between different product configurations for high-speed filling lines in an isolator environment, and all other activities downstream of the sterile filter.

　　Responsible for overseeing and executing formulation activities including but not limited to setup, thaw, weigh/dispense, compounding, dilution, and all other activities upstream of the sterile filter.

　　Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error.

　　Support strategic plans for process and plant improvements to increase efficiency and manage costs.

　　Work with Tech Transfer and Project Management teams to transition products through the product development timeline.

　　Implement and review operational documentation systems within Manufacturing, Operations and Process Development. Main responsibilities include authoring and implementation of manufacturing procedures and batch records. Drafting SOPs, addressing comments, incorporating edits, and issuing final drafts for approval.

　　Effectively collaborate with other team members, production operators, engineers, microbiologists, analytical chemists, project managers, and senior management.

　　Assist engineering and validation with implementation, commissioning, and validation of clean room spaces and process equipment.

　　Take corrective action by thinking creatively, solve problems, and develop innovative solutions based on sound scientific analysis.

　　Initiate revisions to cGMP procedures, and master batch records as applicable.

　　Full job description available during formal interv