Cleaning Validation Lead

We now wish to recruit a Cleaning Validation Lead Engineer to support several projects for a client in the region of Geel.

PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of more than 3,700 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors.

Our Vision is to be a highly valued and creative delivery partner, building a more sustainable world with our clients.

Our OTS (Outsourced Technical Services) department supports projects in different sectors on basis of project staffing with consultants working at the client’s site.

The Workstream Lead for Cleaning Validation & Cleaning Operations has the responsibility to co-lead (in partnership with the local process owners) the effort to bring all existing cleaning validation and cleaning operations efforts on the J&J Geel IM site in line with current industry best practices (including the dimension of risk management). On-site presence is required for min 80%.

Essential duties and responsibilities

• Provide direction on cleaning validation and cleaning operations best practices and corresponding science-based risk management approaches
• Oversee the various projects and corresponding resources (contractors), applying diligent project management practices and controls, to assure delivery vs plan
• Assure quality and compliance (with internal and external regulatory requirements) of projects outputs & deliverables, while closely partnering with the corresponding QA lead to assure full alignment
• Drive change management to the broader organization to assure sustainable adoption of best practices
• Mentor and coach the Local process owner (LPO) to uplift his/her knowledge to reflect industry best practices

Required qualifications:

• Deep understanding and experience of equipment cleaning and cleaning validation in a pharma manufacturing environment
• Experience in API environment preferred
• Deep understanding of both FDA and EMA requirements towards cleaning and cleaning validation, including hands on experience with risk-based approaches and creation of validation documents.
• Excellent project management skills, organizing, planning and coordination skills
• Strong interpersonal & communication skills
• Experience in leading teams in complex / dynamic environments
• Coaching, human change management and training skills
• Ability to navigate politics, interact at different levels of the organization, and influence without authority
• Languages; English (must), Dutch (preferred)

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven.  Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click HERE to read more in our ‘Corporate Responsibility and Health, Safety and Wellbeing Report’.

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