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.
- Exposure to regulatory inspections (ISO, SOX, UL, foreign inspection agencies) 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
Bloom Energy is committed to fair and equitable compensation practices. The total compensation for this position includes standard company benefits and is based on various factors including, but not limited to, relevant skills and experience.
Salary Ranges:$88,600.00 - $127,400.00
