Risk Manager

Risk Manager - Cross Contamination

Location: Geel (onsite) 

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

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 Risk Manager – Cross contamination has the task to develop together with the senior manager drug product and compliance a risk assessment methodology and cross contamination control strategy for cross contamination risks. 

Working in partnership with multifunctional groups and collaboration with the business across departments is a crucial aspect to this role.

A general understanding of quality compliance, change management and risk assessment methodologies in a pharmaceutical company is key.

A deeper understanding and experience of cross contamination risks is preferred.

A general understanding of contamination control and ANNEX 1 is highly valued.

Key Responsibilities:

• Develop (design, pilot and deploy) with a multidisciplinary team a risk assessment for cross contamination risks.

• Design, get buy-in and deploy with a multidisciplinary team a process with roles and responsibilities to assure risk assessments cross contamination are kept up to date during changes (MoC) and are reviewed periodically.

• Prepare, facilitate and document the first FMEAs cross contamination

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

Education & Experience 

• Bachelor's or master’s degree preferably in Chemical Engineering or Process technology (bioengineering, industrial engineering or chemistry), or consistent track record in an industrial, operational environment. 

• General understanding of quality compliance, change management and risk assessment methodologies (FMEA, what if,…) in a pharmaceutical company is key.

• A deeper understanding and experience of cross contamination risks is preferred.

• Technical knowledge of some of the following is highly valued: batch chemical reactors, spray dryers, (post) dryers and centrifuges.

• Experience working in a chemical manufacturing environment is required.

• Owns good change project management, organizing, planning and coordination skills

• Able to set-up and maintain communication with partners and wider network organization

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”.