Google IT Automation with Python

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company’s biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It is capable of meeting all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

This role will be a member of the Process Automation team, reporting to the Process Automation leader. In this role, this individual will be responsible for leading the design of the Manufacturing Execution System (MES)/ Electronic Batch Record (EBR) system with the process operations team, providing automation support during facility start-up activities, continued support of systems after start-up, and actively contribute to continuous improvement projects., * Provide key automation support for various manufacturing systems such as DCS (DeltaV), PLC, MES, SCADA and OEM systems

• Work with process development teams on technical development and the testing of new technologies, trialing new automation strategies, and implementing them in the GMP areas
• Support capital projects, work to design, install, and qualify new equipment to support GMP clinical production. Write, review or execute test documents. Limited off shift work may be required to meet project, operations, and qualification needs.
• Execute and develop appropriate system validation, change control, and testing documentation in partnership with project CQV and IT teams.
• Support establishment of GxP systems in the facility: Change Management, Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems.
• Lead integration of control systems with MES/EBR, Quality, and Batch Reporting applications.
• Understand and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.
• Support and/or Direct Continuous Improvement projects with automation review of equipment specifications, P&IDs, and System Life Cycle documentation
• Responsible for troubleshooting challenging equipment/automation issues to improve manufacturing performance (e.g. yield improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP
• Lead automation related investigations into deviations and implement the corrective actions
• Serve as a technical mentor and help train rotational and new employees, and supervise staff performing GMP activities and deliver training as needed, Union Beach, NJOn-Site Research Chemistry Visionary Innovation Collections Scale (Map) Food Science Distillation Wet Chemistry Detail Oriented Beverage Products Technical Management Laboratory Equipment Artificial Intelligence Engineering Design Process Good Laboratory Practice (GLP) Gas Chromatography Mass Spectrometry High-Performance Liquid Chromatography +0 Assistant Team Leader Actalent Secaucus, NJRemote AutoCAD Planning Visionary Scheduling Leadership Innovation Coordinating Civil Engineering Working at Heights Artificial Intelligence Engineering Design Process MicroStation (CAD Design Software) +0

Writing Biology GE iFix Research Chemistry DeviceNet Operations Leadership Automation Innovation Compassion ControlNet Wonderware Shift Work Biochemistry Adaptability Microbiology Presentations Investigation Cell Cultures Change Control Data Integrity Pharmaceuticals Detail Oriented Clinical Trials Problem Solving Medical Devices Control Systems Telephone Skills System Lifecycle Material Handling Change Management Biopharmaceuticals PROFINET Standards Analytical Testing Automation Systems Process Development Contingent Workforce Technological Change IBM Parallel Sysplex Industrial Engineering Molecular Microbiology Calibration Procedures New Product Development Manufacturing Processes Pharmaceutical Sciences Biochemical Engineering Distributed Control Systems Business Process Automation Code Of Federal Regulations Good Manufacturing Practices Good Documentation Practices Corrective Action Management Programmable Logic Controllers Continuous Improvement Process Troubleshooting (Problem Solving) DeltaV Distributed Control System Manufacturing Execution System (MES) Commissioning Qualification Validation (CQV) Supervisory Control And Data Acquisition (SCADA), * Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 4 years relevant experience, or a master’s degree with minimum years of relevant experience.

• Administration experience with MES/EBR platforms, such as Syncade, PAS-X, or similardo.

Preferred Experience and Skills:

• At least 4 years of experience in an Automation or Engineering function for Biologics, Food, Medical Devices, or Pharmaceutical industries
• Proven experience with development and implementation of industrial controls such as DCS (Delta V), SCADA (Wonderware, iFix), PLC applications (Siemens, Allen Bradley), Historian (PI)
• I/O Networking experience (i.e. Ethernet/IP, OPC, Profinet, ControlNet, Profinet, DeviceNet, and ModBus protocols) is advantageous
• Working experience with GAMP, S88 and other industry standards.
• Commissioning and qualification test protocol development and execution
• Track record of working effectively with team-members of skill sets and backgrounds
• Strong presentations and verbal/written communication skills
• Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to biologics development
• Excellent attention to detail, highly independent with initiative
• Excellent troubleshooting and problem-solving skills
• Ability to challenge the status quo with a continuous improvement mindset, Adaptability, Analytical Testing, Biochemistry, Continuous Process Improvement, Control Systems Integration, Corrective Action Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Manufacturing, Manufacturing Execution Systems (MES), Molecular Microbiology, New Product Development, Technical Problem-Solving, Data Analysis Data Security Detail Oriented Microsoft Excel Risk Management Compliance Risk Microsoft Office Ad Hoc Reporting Data Warehousing Analytical Skills Quality Assurance Loan Documentation Workflow Management Microsoft PowerPoint Credit Risk Management Business Administration Web Application Security Document Management Systems Standard Operating Procedure Ethical Standards And Conduct Customer Relationship Management +0

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is $117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.