Senior Engineer - Automation

The incumbent must be independent, goal-oriented, flexible, able to work efficiently across multiple projects, enthusiastic, and innovative, with a solid understanding of good manufacturing practices and technologies to support the needs of the Site/Network Manufacturing Teams.

Responsibilities

• Subject matter expert for the process automation systems and equipment.
• Lead complex technical efforts, such as large scope changes or difficult integrations.
• Initiate Process Automation System continuous improvement to improve operational robustness and efficiency.
• Work in collaboration with Validation, Quality and Manufacturing Engineering and Manufacturing operations to keep the operations on site functional.
• Support key business processes such as audit, investigation and CAPA.
• Provide troubleshooting and guidance support to automation systems in support of Manufacturing as part of daily responsibilities and a 24/7 on-call rotation.
• Support Automation system life cycle to ensure the procedures and processes are in compliance with quality requirements.

Knowledge & Skills

• Ability to lead, train, foster a cohesive team, and coach, develop, delegate, and motivate others.
• Strong critical reasoning, decision-making, and strategic thinking skills with the ability to translate strategy into actionable plans.
• Excellent organizational and time management skills, including the ability to prioritize and manage multiple tasks and expectations in a fast-paced environment.
• Ability to work independently and in cross-functional teams with moderate supervision.
• Strong verbal and written communication skills; able to communicate honestly, transparently, and effectively with peers, department management, and cross-functionally, including advanced technical document writing.
• Knowledge of the relationship between manufacturing processes, ERP, PCS, and MES preferred.
• Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object lifecycle management preferred.
• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques preferred.
• Experience with manufacturing boundary systems preferred.
• Ability to travel 10%–15% of time.

Minimum Requirements

• Bachelor's degree required in Engineering, Biological/Life Sciences, Chemistry, Biochemistry, or related field, along with 5 years of relevant work experience or equivalent combination of education and work experience.
• 4+ years’ experience with DeltaV, PI Historian, and OT Infrastructure.
• Expert understanding of S88, S95, and batch processing operations.
• Expert understanding engineering documentation such as P&IDs, network diagrams, process flow diagrams, and SOPs.
• Expert understanding of Validation Lifecycle Management, including the planning, creation, and execution of IQ’s, OQ’s, and PQ’s.
• Experience with QMS systems (Veeva, or similar) and GMP Quality Processes (Deviation Management, Change Controls, etc.) required.
• Experience with IT Ticketing Systems (ServiceNow or similar).
• Excellent communication skills including oral, written, and formal presentations.
• Ability to clearly communicate technical information to a variety of audiences.
• Exercise sound judgment in making decisions and recommendations within generally defined practices and policies and notify senior management when necessary.