Change Control, Change Management, Communication Skills, Contract Manufacturing, Cross-Functional, Documentation, FDA Requirements, ISO (International Organization for Standardization), Manufacturing, Manufacturing Engineering, Manufacturing Operations, OEM (Original Equipment Manufacturer), Process Control Engineering, Process Development, Process Engineering, Process Flow, Process Flow Diagram (PFD), Process Improvement, Process Validation, Production Support, Quality Assurance, Quality Engineering, Quality Management, Requirements Validation/Verification, Risk, Risk Management, Support Documentation
SUMMARY: Red Star Manufacturing is seeking a Process Lifecycle Engineer to lead the definition, control, and governance of production processes within a regulated environment. This role ensures special and regulated processes are clearly defined, risk-based, validated, and sustained through an effective Quality Management System (QMS). This role reports to the Director of Quality Assurance and partners closely with Manufacturing Engineering and Operations to ensure production processes are supported by clear documentation structures, sound validation strategies, and consistent lifecycle controls, with a focus on process system design and governance rather than day-to-day manufacturing execution.
ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)
- Establish and maintain process lifecycle frameworks (definition, validation, change management, sustainment)
- Define clear, traceable process structures linking requirements, risks, controls, and records
- Develop and maintain QMS procedures and documentation hierarchies for process control
- Create process flows, control strategies, and risk-based decision frameworks
- Lead governance of special processes, including validation and change control
- Define validation strategies aligned with process risk and complexity
- Partner cross-functionally with Quality, Engineering, and Operations to ensure consistent process implementation
QUALIFICATION REQUIREMENTS:
- Bachelor's degree in Engineering or a related technical discipline preferred.
- 5+ years of demonstrated, directly applicable experience designing, governing, and sustaining processes in a regulated manufacturing environments, required
- Candidates with 10+ years of relevant experience may be considered in lieu of a formal engineering degree, with demonstrated systems thinking, sound technical judgment, and ownership of comparable process lifecycle responsibilities
- Demonstrated experience defining, governing, or improving process control frameworks and lifecycle systems
- Strong working knowledge of Quality Management Systems (QMS), including process control, validation, and change management
- Experience applying risk-based validation strategies and aligning with regulatory expectations (FDA, ISO 13485)
- Experience developing process flow diagrams (PFDs), control strategies, and decision matrices
- Familiarity with special processes and their validation/control requirements
- Background in OEM or contract manufacturing environments, preferred
OTHER SKILLS AND ABILITIES:
- Ability to establish structure, frameworks, and governance where formal systems may not yet exist.
- Ability to work independently in complex and evolving environments
- Skilled in translating complex process logic into clear, auditable documentation and decision frameworks
- Clear communication across technical and cross functional teams