Manufacturing Support Scientist/Engineer - 6 Month Contract (61163)
Responsibilities
• Contributes to cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product start-ups or other process changes
• Support new product introduction risk assessments to ensure the appropriate controls are in place to enable manufacturing
• Support product change over protocols to allow a smooth transition from sustaining to new product manufacturing
• Represent the Manufacturing at meeting to ensure the end user requirements are represented
• Supports process technology transfer, and the preparation of manufacturing documentation for development, engineering and PPQ batches.
• Identify process improvement projects for New Product Introduction and support projects to completion.
• Work with sustaining team to understanding current issues and ensure impact of new products are defined, agreed and understood
• Write process impact assessments to support new product introduction
• Provide SME input into cross-functional teams investigating & optimizing new manufacturing processes, procedures and documentation.
• Provide training to BPAs on new procedures.
• Support external and internal audits.
• Work with cross-functional teams on the introduction of consumables and raw materials to support New Product Introduction .
• Work to implement a “Right-First Time Culture” and provide leadership in the use of OE principles.
• Support the disposition process when required
• Carry out organizational activities such as purchasing & co-coordinating communication information.
• Own & drive change controls, CAPA’s, investigations, improvement projects and operational safety.
• Departmental Approver of operations procedures, electronic batch records and other GMP documentation and provide technical training and knowledge transfer to the Operations team.
Qualifications and Experience
• Ability to demonstrate proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills. In addition, must have proven success working in a team environment, as well as strong leadership & influencing skills, with flexibility to react to changing business needs. Problem solving and project management ability, as well as lean manufacturing experience is essential.
• Currently completing a Bachelors/Masters in Science, Engineering, or a related subject.
• In-depth theoretical knowledge of GMP biologics manufacturing equipment and process automation.
• Proven ability to support the closeout of complex technical investigations.
• Strong working knowledge of systems such as Delta V, MES Syncade and SAP.
• Excellent presentation skills.
