Robert Bea Email & Phone Number

Berkeley, CA, US

Blue Bell, PA, US

West Coast group lead responsible for providing leadership and support for a team of process automation engineers.

Leverkusen, North Rhine-Westphalia, DE

• Final Product Manufacturing (FPM) engineering director responsible for providing leadership and direction for engineering team. Responsibilities:
• actively manage and provide strategic guidance to a multi-disciplined group of seven plant engineers,
• recruit, hire, and mentor plant engineering personnel to improve team technical and management skills,
• ensure reliability of FPM process equipment, facilities, and utilities through predictive and reactive maintenance, and
• represent FPM engineering in regulatory inspections and function as an expert for FPM processes.

Leverkusen, North Rhine-Westphalia, DE

• Quality Assurance (QA) project engineer responsible for providing leadership and support for site projects. Responsibilities include:
• optimization of quality risk management standard operating procedures (SOPs),
• ongoing support and site-wide training to track and categorize the site’s risk assessments,
• acting as quality evaluator for discrepancy investigations and reports,
• leadership and support for the commissioning and qualification of a new laboratory facility, and
• enhancement of the compliance culture by working with diverse groups to improve SOPs and practices.

Leverkusen, North Rhine-Westphalia, DE

• Principal Process Control Systems (PCS) engineer dedicated to a pharmaceutical freeze drying, filling, and packaging facility. Equipment includes steam sterilizers, filler and stopper setter, automated loading and.
• act as delegate for plant engineering manager in his absence,
• manage project change control request (CCR) process, ensure adherence to quality requirements, and maintain compliance with industry and company regulations and procedures,
• program and repair automation systems (Siemens Step 7, WinCC, Allen Bradley Control Logix) to support daily operations and increasing facility production,
• support the resolution of production discrepancies by partnering with quality team members,
• lead the implementation of revised lock-out and tag-out (LOTO) procedure for bi-annual facility shutdown,

Leverkusen, North Rhine-Westphalia, DE

• Lead automation Validation Engineer responsible for developing state-of-the-art software and automation validation life-cycle documentation. Responsibilities include:
• developed templates and procedures for the commissioning and validation lifecycle for software of GMP manufacturing control systems,
• led efforts to establish a culture of excellence by influencing engineering and validation groups to ensure consistent application of best practices,
• supervised and supported software validation test work execution in collaboration with internal engineering groups and external service providers, and
• acted as subject matter expert in maintaining internal software validation practices.

Basel, Baselstadt, CH

• Lead project PCS engineer for an innovative influenza cell culture manufacturing site’s filling, packaging and warehouse facilities. Responsibilities and accomplishments:
• selected filling area equipment including systems for formulation, electron beam decontamination, syringe filling, inspection, and packaging,
• authored standard operating procedures (SOPs) for the change management of control system documentation and the risk assessment of control system instrumentation, and
• streamlined the commissioning and qualification process by partnering with Quality Assurance to accept vendor testing and documentation.

Emeryville, California, US

• Lead project PCS engineer for the design and construction of a buffer preparation and supply facility. Responsibilities and accomplishments:
• reviewed and revised process flow diagrams (PFDs), piping and instrumentation drawings (P&IDs), and electrical single line and control loop drawings,
• expedited validation and minimized costs by utilizing commissioning activities for system qualification,
• modified control system to meet changing production requirements (Allen Bradley ControlLogix, PanelView Plus, RS Logix5000, RS View ME), and
• received Star Award for “Providing Outstanding Leadership and Technical Support in Engineering, Commissioning and Validation.”Lead effort to establish standards for documentation, testing, and control of GxP systems..

Leverkusen, North Rhine-Westphalia, DE

• Plant PCS engineer dedicated to a pharmaceutical freeze drying, filling, and packaging facility. Fill line equipment included vial washers, steam sterilizer, tunnel sterilizers, fillers, stopper setter, vacuum.
• supervised two PCS engineers,
• repaired fill line equipment and instrumentation (Allen Bradley SLC 5/04 and PanelView),
• provided troubleshooting for freeze dryer automation and mechanical systems, and
• investigated process discrepancies and implemented corrective and preventative actions.