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will provide process validation leadership for one or more vaccine or biologics drug substance manufacturing processes. The position leads and/or participates in the planning, preparation, execution, and
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. Proven experience with PLC Allen Bradley/Rockwell/Siemens. Able to define multi-year strategic Automation direction. Collaborate and align with above site/Global teams. PSM Process Safety Management
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. Proven experience with PLC Allen Bradley/Rockwell/Siemens. Able to define multi-year strategic Automation direction. Collaborate and align with above site/Global teams. PSM Process Safety Management
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corporate objectives within established budgets. Has primary responsibility to monitor product cost by controlling BOM and process changes impacting cost or overall performance. Owns the strategic plan
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regulations Independently conducts wide range of routine/(non-routine) complex investigator site audits (minimal to no oversight - as needed) Executes audit strategy, leads/supports process audits, and may
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development process. Collaborates with project teams, subject matter experts, and quality lines to e nsure clear, factual, effective, and appropriately concise presentation of analyses and associated
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throughout the labeling review and approval process through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external
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collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS This position/role works
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. Strong understanding of the drug development process and regulatory submissions. Proficiency in Microsoft Office applications (Word, PowerPoint) and collaborative authoring tools (Endpoint, Starting Point
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experience in Automation Engineering Experience with process controls equipment; design and debugging skills Broad understanding of systems architecture and operations, and related components Excellent project