MSAT Bio Engineer

MSAT Bio Engineer 

Location: Open to residents of Cork, Barnahely, Ireland OR Leiden, Netherlands

Duration: 12 months

Hours: Full time working hours, Monday to Friday. Hybrid (3 days on-site)

Imagine your next project as a MSAT Bio Engineer, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

Day-to-day DS Product Support

• Lead and drive product related investigations supporting external manufacturing and internal sites (NC technical input/owner)

• Author/review protocols/reports as required

• Raise and support progress of Change controls interacting with different areas and ensuring timely response/closure.

• Perform data analysis across different manufacturing sites

• Sample management support – coordinate shipping of samples between manufacturing site and testing site/storage location, ensure tracking of samples is kept up to date and provide required legal paperwork for shipments.

• Lead and coordinate small projects in support of manufacturing

• Good Manufacturing Practices (GxP)

• cGxP technical writing skills 

• Adhere to applicable cGxP’s and procedures (role model)

• Ability to make decisions (shop floor) based on qualitative impact assessment.

• Evaluate and timely report observed quality issues.  Provide recommendations for corrective actions. 

• Actively promote EH&S, support campaigns/programs such as “Safe behavior’

• Act when violation of EH&S rules is observed and stimulate appropriate behavior

Process Optimization

• Identify improvement opportunities and detail the execution/feasibility/implementation of the project

• Work with GTOs/TLIs to support process improvement projects by owning actions

how to succeed

You will have the ability to work under pressure, handle conflicting interests, and make decisions. You will also have strong stakeholder management experience and strong problem solving skills. You will also bring:.

• Strong experience in a similar position within Bio (6-10 years experience)

• Fluency in English

• Knowledge of pharmaceutical manufacturing processes & products and/or equipment & facility engineering across in biologics DS. 

• Knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) in biologics DS.

• Knowledge of manufacturing site systems and procedures.

• Proven knowledge/experience in the field of database systems and extraction of raw data from those systems.

• Basic knowledge in automation of data extraction from repository systems.

• Experience in Process validation

• Knowledge of Cleaning Validation

• Knowledge of CPV

benefits

This role offers a very competitive hourly rate. This contract will run for a 12 month duration.

you are welcome here

Janssen Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

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. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

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”.