**Manufacturing Support Scientist/Engineer - 6 Month Contract**
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.
• Supports new product introduction risk assessments to ensure the appropriate controls are in place to enable manufacturing.
• Supports product change over protocols to allow a smooth transition from sustaining to new product manufacturing.
• Represents the Manufacturing at meetings to ensure end-user requirements are represented.
• Supports process technology transfer, and the preparation of manufacturing documentation for development, engineering, and PPQ batches.
• Identifies process improvement projects for New Product Introduction and supports projects to completion.
• Works with sustaining team to understand current issues and ensures the impact of new products is defined, agreed, and understood.
• Writes process impact assessments to support new product introduction.
• Provides SME input into cross-functional teams investigating & optimizing new manufacturing processes, procedures, and documentation.
• Provides training to BPAs on new procedures.
• Supports external and internal audits.
• Works with cross-functional teams on the introduction of consumables and raw materials to support New Product Introduction.
• Works to implement a "Right-First Time Culture" and provides leadership in the use of OE principles.
• Supports the disposition process when required.
• Carries out organizational activities such as purchasing & coordinating communication information.
• Owns & drives change controls, CAPA's, investigations, improvement projects, and operational safety.
• Departmental Approver of operations procedures, electronic batch records, and other GMP documentation and provides 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 Bachelor's/Master's 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.