Manufacturing Change Control Lead

101 Bloom Energy; United States; On-site; USD 88,600 - 127,400; Full time

Job summary

Bloom Energy in Newark, DE is seeking a Manufacturing Change Control Manager to own the change control system and ensure ISO 9001:2015 compliance. This role drives governance across Operations, Quality, Engineering and Supply Chain, ensuring changes are properly assessed, approved, implemented, and tracked.

You will lead audits, CAPAs, BOM updates, and improvements while mentoring the team and coordinating across sites to harmonize workflows and reporting.

Qualifications

• Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, or related field.
• 5–8+ years in manufacturing, quality, or technical operations within a regulated environment.
• 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.
• Familiarity with technical documentation (BOM, Drawings, Specifications, etc.).
• Experience working cross‑functionally in a regulated manufacturing organization preferred.

Responsibilities

• 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.
• 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.
• Lead responses to audit observations related to change control and manufacturing changes.

Skills

Change control management

ISO 9001:2015

Cross-functional collaboration

Documentation governance

Regulatory inspections

Project management

Lean/Six Sigma

Education

Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, or related field

Tools

PLM tools

Oracle PLM

Job description

Bloom Energy in Newark, DE is seeking a Manufacturing Change Control Manager to own the change control system and ensure ISO 9001:2015 compliance. This role drives governance across Operations, Quality, Engineering and Supply Chain, ensuring changes are properly assessed, approved, implemented, and tracked.

You will lead audits, CAPAs, BOM updates, and improvements while mentoring the team and coordinating across sites to harmonize workflows and reporting.