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Purpose and Scope The Manufacturing Operations Engineer II 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 II assists with/leads protocols and changes for the Manufacturing Department and provides hands 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 (EBR) 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 EBR. Ensures exceptional support for Freeweigh and EBR and works to continuously improve the systems and customer experience. Owns manufacturing change controls associated with CAPA actions and process improvements. Independently leads cross-functional project teams. 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 of the manufacturing operation. Mastery of current Good Manufacturing Procedures (cGMP). Knowledge of US and European Industry Regulations pertaining to producing in a clean and GMP environment. Electronic Document Management System (EDMS) experience. Strong 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 employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together. Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes. Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality. Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience Bachelor's Degree in Engineering or similar field required. 3 years' experience Required: Three or more years of experience in a GMP manufacturing role within the pharmaceutical or medical device industry preferred.