Equipment Validation Lead

Equipment Qualification Lead 

Location: Geel (onsite) 

Hours: 32/40 hrs Contract Dec 31st (with possible extension)

Languages: English (essential) Dutch (preferred) 

Essential:  Experience of cross contamination risks, APIs, previously worked within a pharma or bio-chemical manufacturing environment (essential) 

The Company:  

The chemical production facility in Geel, Belgium is part of the Johnson & Johnson Innovative Medicine organisation and is a manufacturer of active pharmaceutical ingredients (APIs). 

The Role:

The Squad Lead for Equipment Qualification has the responsibility to co-lead (in partnership with the local process owner) the effort to bring all existing equipment qualifications on the J&J Geel IM site in line with current industry best practice on risk based approaches. On-site presence is required for min 80%.

Essential duties and responsibilities

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

• nt the first FMEAs cross contamination

• Support the senior manager drug product and compliance with complex quality incidents/improvements.

Required qualifications:

• deep understanding and experience of equipment qualification in a pharma manufacturing environment

• experience in API environment preferred, including experience with batch chemical reactors, spray dryers, (post) dryers and centrifuges.

• deep understanding of both FDA and EMA requirements towards equipment qualification, including hands-on experience with risk-based approaches and creation of qualification 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)

Benefits

This role offers a competitive hourly rate & a supportive working environment. 

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

https://www.jnj.com/healthcare-products/medtech

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. Please apply via the link.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.