Change Control Lead – Manufacturing Excellence

Bloom Energy

Newark (DE)

On-site

USD 89,000 - 127,000

Full time

14 days+

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Job summary

Bloom Energy in Newark, DE is seeking a Manufacturing Change Control Manager for an on-site role reporting to the Sr. Manager, Operations.

You will own the change control system, ensure ISO9001:2015 compliance, and drive governance across Manufacturing Operations, Quality, Engineering, and Supply Chain to maintain product quality and supply continuity. The role emphasizes leadership, audit readiness, CAPA initiatives, and continuous improvement within a regulated manufacturing environment, with

Qualifications

Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, or a related technical field.
5–8+ years in manufacturing, quality, or technical operations within a regulated environment.
Experience owning change controls and working with PLM tools.
Working knowledge of ISO 9001:2015, regulatory compliance, and quality systems.
Experience cross-functionally in a regulated manufacturing organization.

Responsibilities

Lead manufacturing change control system governance and ensure compliance with quality systems and ISO9001:2015 procedures.
Define and manage change initiation, impact assessment, approvals, implementation, and closure.
Ensure changes are risk-assessed and aligned with product quality and supply continuity.
Serve as SME for change control during audits and regulatory inspections.
Coordinate cross-functional teams to schedule deviations, training, and line readiness; chair governance forums.