MS&T Manufacturing Operations Engineer; Temporary Onsite

Position: MS&T Manufacturing Operations Engineer (Temporary 6 months) Onsite
Purpose and Scope

The Manufacturing Operations Engineer I provides technical support for manufacturing processes for specialty injectable and aseptic products while ensuring those products are made with quality for our patients. The Manufacturing Operations Engineer I assists with protocols and changes for the Manufacturing Department and provides hand-on and technical support for other department projects when dealing with Manufacturing. Owns Quality Event investigations and supports equipment troubleshooting / updating / installing.

Manufacturing Operations Engineers are system owners for the Electronic Batch Records (E ) and Freeweigh systems and serve as the manufacturing technical point of contact for Enterprise Resource Planning (ERP) projects.

Essential Duties and Responsibilities

• Serves with members of manufacturing engineering team as system owner of Freeweigh and E .
• Ensures exceptional support for Freeweigh and E  and works to continuously improve the systems and customer experience.
• Owns manufacturing change controls associated with CAPA actions and process improvements.
• Drives cross-functional projects with support from senior team members and management.
• Manages scope, timeline, escalation, and communication of projects.
• Uses continual improvement and data analysis tools to identify issues in manufacturing processes impacting quality and efficiency, working to resolve them with the manufacturing and other support departments.
• Works closely with Operations to identify process inefficiencies, bottlenecks, training needs, and continual improvement initiatives.
• Acts as the liaison between Manufacturing and other departments for support with other changes/projects.
• Supports new equipment qualifications, installations, and calibrations for the manufacturing department, including protocol / report generation from other Engineering Departments.
• Provides Change Assessments for impact to Manufacturing for company changes and closes Change Actions correlated with Change Controls.
• Acts as a point of contact for contractors / outside vendors for issues pertaining to Manufacturing.
• Provides Technical QE investigator and major/minor QE support for the manufacturing department.
• Writes, edits, and routes Work Instructions and SOPs in electronic document system including using the change control process.
• Works with engineering department in cross functional team environments, analyzing and understanding defects and working to optimize processes.
• Performs other duties as assigned.

Knowledge, Skills & Abilities

• Proven capability in collaborating in multi-level, cross-functional teams to provide daily support for the manufacturing operation.
• Strong understanding of current Good Manufacturing Procedures (cGMP).
• Knowledge of US and European Industry Regulations pertaining to production in a clean and GMP environment.
• Electronic Document Management System (EDMS) experience.
• Knowledge in utilizing Microsoft Office (Excel, Word, and Outlook) and Adobe.
• Ability to maintain focus on detail-oriented and highly technical tasks.
• Ability to follow, understand, and revise standard operating procedures and production records.
• Strong math, writing, and technical skills. Strong attention to detail.
• Knowledge of chemistry, engineering principles, and pharmaceutical industry.
• Ability to accurately read and document data from various process instrumentation.
• Ability to quickly make decisions and understand the impact on processes and product quality.
• Ability to interact with peers and other coworkers from all departments/locations in team settings in a professional manner.
• Ability to coordinate project timelines with support departments in a clear and effective manner to ensure critical timelines are met.
• Ability to lead by example and have excellent attendance, quality of work, dependability and safety mindset.
• Ability to communicate technical details of specialty injectable process to members of every department in a professional and effective manner.

Core Values

This position is expected to operate within the framework of Tolmar's Core Values:

• Center on People:
  We commit to support the well-being of our patients. We are committed to treating our…