Associate Specialist, Process and Instrumentation Engineer

MSD • Elkhorn, NE

5d • Hybrid

About The Position

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. The selected applicant will develop and maintain the Engineering, Maintenance, Automation, and Calibration teams in high levels of process support and maintainability. The Process and Instrumentation Engineer will be the authority on Key Operating Parameters, Critical Attributes, and Critical Process Parameters within the Engineering and Maintenance department. As a crucial part of this role, the Process and Instrumentation Engineer will serve as a Calibration System Administrator. The Calibration Administration provision of this role will be responsible for defining, documenting, qualifying, and communicating the calibration details of process and utility instrumentation under the Calibration Program. Due to the Process and Instrumentation Engineer’s deep knowledge of the process requirements and the systems that maintain those requirements; the role will play a critical role in defining new processes, change management, deviation investigation, process improvement, and efficiency improvement. The Process and Instrumentation Engineer will work closely with Project Managers, Maintenance Personnel, Calibration Personnel, Automation Engineers, Quality Assurance, Process Development, Production Management, and multiple levels of management to deliver on the goals of the organization. The Elkhorn, NE site is a key supplier of companion and food animal vaccines for our Animal Health Network. Within the global manufacturing and technology, Elkhorn delivers biological production, QC, R&D, animal care, process development, and support services on an 100+ acre site. Primary Areas of Expertise for the Process and Instrumentation Engineer Process Definition and Documentation through PFDs, P&IDs, SOPs, Process Guide Documents, Picture Maps, and training. Critical Parameter Hierarchy Definition for Instrumentation selection and calibration job plan development. Regulation, corporate standard, and site policy interpretation and application to a broad range of production, automation, equipment, and human processing scenarios. The position requires the ability to effectively work on a computer, in specialized computer programs, in the Production Environment, in Utility areas, and across all areas of the site. The position will support team members in Production, Clean room, utility, waste treatment, and outdoor spaces, as the role will be responsible for processes and instrumentation across all locations and applications on the site. Reading and understanding a broad variety of sources will be daily, from process drawings, electrical drawings, piping diagrams, automation design documents, construction specifications, SOPs, Process documentation, and instrumentation specifications. Communication is the cornerstone of this role and the ability to connect with anyone in the organization will be a key determining factor in success in the role. Review, Route and enter new instrumentation into the Computerized Calibration Management System. Develop and maintain Process Flow and Block Diagrams for new, existing, and changing processes. Support Biological processes supporting vaccine production including: Fermentation, Concentration, Clarification, Blending, Sterile Filling, Freeze Drying, Serialization, and Packaging. Support change controls for process improvements. Support deviations and root cause analysis with corrective and preventive action implementation.

Requirements

• Bachelor of Science in Engineering degree required (MechE, ChemE, EE, or BSEng).
• 0-3 years of relevant industry work experience
• Adaptability
• Biopharmaceutical Operations
• CAD Proficiency
• Data Analysis
• Engineering Principle
• Engineering Standards
• Estimation and Planning
• Experimentation
• Instrumentation
• Instrumentation Engineering
• Process Optimization
• Professional Engineering
• Project Management
• Software Proficiency
• System Control
• Teamwork
• Technical Communication
• Technical Problem-Solving
• Sit, stand, walk for up to 8 hrs per day in construction, production, utility, or office areas.
• Lift and carry up to 25 lbs. on a regular basis.
• Climb stairs and ladders to access and observe process conditions.
• Computer work, including writing, CAD, mathematical software, and Computerized Calibration Management System administration.
• Unconditioned space work at times to observe and support process and utility conditions.
• Outdoor work occasionally to observe process and utility conditions.

Nice To Haves

• Previous role as a Process Engineer, Commissioning & Qualification Engineer, Quality Assurance Specialist, Automation Engineer, Instrument Engineer, or Calibration Administrator is preferred.

Responsibilities

• Develop and maintain the Engineering, Maintenance, Automation, and Calibration teams in high levels of process support and maintainability.
• Serve as a Calibration System Administrator.
• Define, document, qualify, and communicate the calibration details of process and utility instrumentation under the Calibration Program.
• Define new processes, change management, deviation investigation, process improvement, and efficiency improvement.
• Work closely with Project Managers, Maintenance Personnel, Calibration Personnel, Automation Engineers, Quality Assurance, Process Development, Production Management, and multiple levels of management to deliver on the goals of the organization.
• Process Definition and Documentation through PFDs, P&IDs, SOPs, Process Guide Documents, Picture Maps, and training.
• Critical Parameter Hierarchy Definition for Instrumentation selection and calibration job plan development.
• Regulation, corporate standard, and site policy interpretation and application to a broad range of production, automation, equipment, and human processing scenarios.
• Review, Route and enter new instrumentation into the Computerized Calibration Management System.
• Develop and maintain Process Flow and Block Diagrams for new, existing, and changing processes.
• Support Biological processes supporting vaccine production including: Fermentation, Concentration, Clarification, Blending, Sterile Filling, Freeze Drying, Serialization, and Packaging.
• Support change controls for process improvements.
• Support deviations and root cause analysis with corrective and preventive action implementation.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees