Equipment Qualification Squad Lead

CSV & DI Squad Lead
Location: Geel, BE | Industry: Medical Devices | Full-time

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Equipment Qualification Squad Lead

The Squad Lead for Equipment Qualification will co-lead, together with the Local Process Owner, the initiative to align all existing equipment qualifications at the J&J Geel IM site with current industry best practices, focusing on risk-based approaches. An on-site presence of at least 80% is required.

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Essential Duties and Responsibilities

• Provide direction on equipment qualification best practices, applying science-based and risk-based methodologies

• Oversee multiple projects and related contractor resources, ensuring delivery to plan through strong project management practices

• Ensure quality and compliance with internal and external regulatory requirements, in close alignment with the site QA lead

• Drive change management efforts to enable sustainable adoption of improved qualification processes across the organization

• Mentor and coach the Local Process Owner (LPO) to elevate their expertise in line with industry standards

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Required Qualifications

• Strong expertise and hands-on experience with equipment qualification in a pharmaceutical manufacturing environment

• Preferably experienced in an API setting, including knowledge of batch chemical reactors, spray dryers, (post) dryers, and centrifuges

• In-depth knowledge of FDA and EMA expectations regarding equipment qualification, with practical experience in risk-based approaches and qualification documentation

• Excellent organizational, planning, and coordination skills with a strong project management mindset

• Strong interpersonal and communication skills

• Proven experience leading teams in complex, fast-paced environments

• Skilled in coaching, training, and change management

• Ability to navigate organizational dynamics, communicate across levels, and influence without direct authority

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Interested?
Interviews and offers can happen within the next two weeks.
If you’re interested in this opportunity, please apply with your CV today.

For more information, contact:
Sandro Canelas Alves
Phone: +31 6 3150 1862
Email: s.canelas@panda-int.com