Familiarity with regulatory standards like ISO9001:2015 and safety principles
Strong organizational, prioritization, and project management capabilities
Effective communication and cross-functional influencing skills
Lean, Six Sigma, or quality-related certifications preferred
Responsibilities
Lead the manufacturing change control system and ensure compliance with all standards
Establish governance for change initiation through closure processes
Risk-assess changes to align with quality and safety standards
Serve as subject matter expert for audits related to change control
Partner with cross-functional teams to prepare for production changes
Analyze change control metrics to drive process improvements
Mentor and develop team members while fostering accountability
Benefits
Opportunities for professional development and continuous learning
Mentorship in a supportive working environment
Access to advanced digital tools and technologies for process improvement
Employee involvement in strategic planning and operational decision-making
Dynamic work environment with exposure to cutting-edge manufacturing processes
Full Job Description
We are looking for a Manufacturing Change Control Manager to join our team in one of today's most exciting technologies. This role will report to the Sr. Manager, Operations and based in Newark, DE. This is a fully on-site, in office role.
Role and Responsibilities:
Change Control Leadership & Governance
Own and lead the manufacturing change control system, ensuring compliance with documentation standards, Quality systems, and regulatory requirements, along with stated ISO9001:2015 procedures.
Establish and maintain clear governance for change initiation, impact assessment, approval, implementation, effectiveness checks, and closure.
Ensure manufacturing changes are appropriately risk-assessed and aligned with product quality, safety, and supply continuity.
Serve as the subject matter expert (SME) for change control processes during internal and external audits.
Cross-Functional Coordination
Partner with Manufacturing Operations, Quality, Engineering, Supply Chain, Regulatory, and Technical Operations to schedule deviation runs in production, confirm operator training and line readiness before execution.
Facilitate change control boards (CCBs) or similar governance forums as applicable to the manufacturing process.
Interpret Bill of Material (BOM) changes and documentation updates: ensure BOMs, drawings, specs, routings, work instructions, and quality documents are updated, released, and version-controlled before use.
Compliance & Audit Support
Ensure change control documentation meets regulatory expectations (ISO9001:2015 and Internal Standards as applicable).
Lead responses to audit observations related to change control and manufacturing changes.
Proactively identify compliance gaps and implement corrective and preventive actions (CAPAs).
Continuous Improvement
Ensure deviation results are tracked, recorded, and communicated back to Engineering for disposition and follow-up actions.
Analyze change control metrics (cycle time, overdue actions, rework, repeat changes).
Drive process improvements to improve efficiency without compromising compliance.
Implement best practices, digital tools, or harmonized workflows across sites where applicable.
Support for automation and dashboarding development to improve communication to senior leadership.
People Management & Development
Lead, mentor, and develop change control and operations professionals.
Set clear performance objectives and foster a culture of accountability, quality, and continuous improvement.
Support succession planning and capability building within the team.
Strategic Contribution
Provide input to manufacturing and quality strategy related to lifecycle management and operational readiness through coordination of kaizen events
Plan and coordinate engineering change implementation in production: cut-in/cut-over strategy, effective dates, line trials, operator training, tooling/fixture updates, workflow routings, work instructions, and inspection plans.
Material Optimization
Manage material disposition: define and execute use-as-is/rework/scrap/return strategy for WIP, finished goods, incoming and on hand inventory; coordinate labeling/segregation of material to prevent mix-ups.
Skills and Experience:
Bachelor's degree in Manufacturing Engineering, Industrial Engineering, or a related technical field preferred.
5-8+ years of experience in manufacturing, quality, or technical operations within a regulated environment.
Prior experience managing or owning change controls and working with Product Lifecycle Management (PLM) tools.
Working knowledge of:
Change control processes
ISO9001:2015
Supply Chain Management & Risk principles
Manufacturing processes and equipment
Familiarity with technical documentation (BOM, Drawings, Specifications, etc)
Experience working cross-functionally in a regulated manufacturing organization preferred.
Experience in a highly dynamic manufacturing environment, especially during periods of rapid growth and change preferred.
Prior people management or team leadership experience preferred.
Experience with Agile and/or Oracle PLM programs preferred.
Lean, Six Sigma, or quality-related certifications preferred. Kaizen event background is a plus.
Strong organizational and prioritization skills.
Project management capabilities in support of new program/process implementation.
Attention to detail and compliance mindset.
Effective written and verbal communication.
Ability to influence cross-functional teams.
Problem-solving and continuous improvement experience.
Physical Requirements:
Ability to stand/walk for up to 10-12 hours per shift
Occasionally lift/carry up to 25-50 lbs
Visual acuity sufficient for product inspection and reading digital/printed materials
Hearing ability to detect alarms and communicate effectively with staff
Ability to perform essential tasks with or without reasonable accommodation
Salary Ranges: $88,600.00 - $127,400.00
About Bloom Energy
Bloom Energy is a provider of solid oxide fuel cell technology. The company's fuel cells generate electricity through an electrochemical process without combustion, producing less greenhouse gas emissions than traditional power generation methods. Bloom Energy's fuel cells are used in a variety of applications, including data centers, hospitals, and manufacturing facilities. The company was founded in 2001 and is headquartered in San Jose, California.
