Process Engineer IV – MS&T

About the Job

The Process Engineer IV is a senior-level technical expert within Manufacturing Science, serving as a partner to biologics manufacturing drug substance operations and custodian of manufacturing processes. This role ensures that manufacturing processes are capable, compliant, in control, cost effective, and continuously improved. The Process Engineer IV provides collocated technical leadership and collaborates across other functions to drive process excellence throughout the product lifecycle. This role will focus on single use technology across drug substance manufacturing and will be responsible for design, troubleshooting, and continuous improvement of complex critical single-use assemblies.

Department Overview

Technical Science partners with biologics manufacturing operations as the custodian of manufacturing processes. The department is responsible for:

• Providing collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement
• Anticipating, responding to, and permanently resolving issues that arise during production
• Aiding in the design of new processes and facilities with expertise in scale-up, manufacturability, PAT, capacity analysis, and cost analysis
• Leading the creation and use of digital process data analytic systems
• Partnering with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process lifecycle improvements

Main Responsibilities

• Provide technical leadership in area of responsibility; deliver technical/scientific support, expertise, and guidance to manufacturing and quality teams
• Lead the design, troubleshooting, and continuous improvement of complex, critical single-use assemblies, such as single-use bioreactor bags, alternating tangential flow devices, nano filtration assemblies, etc., ensuring fit, function, and performance in GMP manufacturing processes
• Ensure a solid understanding of engineering principles and theories in the area of responsibility and apply them to solve a range of complex problems in creative and practical ways
• Apply advanced troubleshooting skills for complex manufacturing deviations
• Lead complex technical project teams or cross-functional teams between groups and organizations; provide input and coordinate support from process development teams
• Review manufacturing processes and/or development and production data to assess process performance and identify opportunities for improvement
• Support documentation preparation for regulatory purposes and stay current on regulatory requirements that impact manufacturing processes; evaluate and implement changes as required
• Provide CMC support and guidance for product lifecycle management

About You

Basic Qualifications

• Bachelor's degree is required. Engineering, science or related disciplines are preferred.
• 5+ years of relevant experience in the pharmaceutical, biopharmaceutical, or other regulated manufacturing industry (GMP).
• Hands-on experience with design, troubleshooting, or continuous improvement of complex critical single-use assemblies.

Preferred Qualifications

• Demonstrated expertise applying fundamental principles to real-world problem solving and providing practical solutions to difficult technical issues
• Experience with biologics upstream or downstream unit operations with perfusion or continuous operations a plus
• Expansive experience leading the design, troubleshooting, and continuous improvement of single use technologies.
• Experience with extractable and leachable
• Understanding of cGMP concepts and familiarity with quality and regulatory frameworks
• Proficiency in process data analytics
• Knowledge of computerized systems in biopharmaceutical manufacturing environments (e.g., DeltaV, Process Data Historian, LIMS, MES)
• Experience leading projects and/or cross-functional teams
• Works independently with minimal supervision and direction; performs work that consistently requires independent decision-making and the exercise of independent judgment and discretion
• Ability to navigate ambiguous circumstances to meet final objectives
• Strong communication and technical writing skills; experience communicating with business partners and senior management

Technical Skills

• Process Data Analytics
• Process Validation & Compliance
• Biologics Manufacturing Operations
• Process Development & Scale-Up
• Manufacturing Systems & Tools

Soft Skills

• Independent Decision-Making
• Cross-Functional Collaboration
• Technical Communication
• Problem-Solving & Ownership
• Mentoring & Leadership

Special Working Conditions

Ability to gown and gain entry to manufacturing areas.