Johnson & Johnson
MSAT Engineer
Location: MSAT Engineer
Duration: 12 months
Hours: 39 hours
We have a great opportunity for a Senior MSAT Engineer to join our MSAT Validation team.
The MSAT Engineer will be responsible for the following:
Active engagement with the MSAT team, delivering a successful outcome to all MSAT validation activities using Good Manufacturing Practices (GMP).
Primary activities are in the Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges, ILC Verification Studies, Chemical Hold Studies) area. Planning, documenting and performing validation studies.
Leading and/or providing technical guidance for process improvement projects and investigations.
Secondary activities include, but are not limited to Thermal Validation, Cleaning Validation, Supporting process improvement projects, Supporting New product Introduction/ process validation, GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents, Exception/Event Investigations)
Roles and Responsibilities
Conduct MSAT activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements.
Develop MSAT documentation (e.g. strategies, plans, protocols, procedures, reports) and co-ordinate MSAT document review and approval.
Review and approve documents prepared by other MSAT colleagues.
Field execution of MSAT protocols.
Liaise with Manufacturing to provide support where required with routine operations / project-based work.
Compile relevant information from contractors, suppliers, and other departments to develop technical reports.
Representing the JSI MSAT site team on platform technical teams.
Initiate and implement change control activities in accordance with site procedures.
Track and resolve exceptions/events/deviations during MSAT activities.
Prioritize MSAT activities in line with Manufacturing / project schedules.
Co-ordinate MSAT activities with contractors and vendors as required.
Attend identified training, required to fulfill the role of a MSAT Engineer.
Participate in multi-functional teams (project, investigations) as required.
How to succeed
A minimum of a Degree in Engineering, Molecular Biology, Biochemistry, Pharmacy or related scientific field is required.
At least 2 yrs experience in the Small Molecule manufacturing industry or equivalent.
Focus on patients and customers at all times.
Desirable:
Experience in Process Support studies (e.g. Mixing Studies, Microbial Hold Studies, Chemical Hold Studies, Media Challenges, ILC Verification Studies) / Thermal Validation (Freezer/ Autoclave studies) (Minimum 2 years).
Also, beneficial would be experience in Cleaning Validation, Process Validation, Supporting process improvement projects, Supporting New product Introduction.
Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.
Ability to work independently under general direction, having a good sense of prioritization of goals and good time management.
Ability to lead multi-functional team and to manage complexity and change.
Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
Benefits
This role offers a very competitive hourly rate. This contract will run for a 12 months and has a strong chance of extension.
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. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella(change as applicable) options are available.
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”.