Johnson & Johnson
MSAT Validation Engineer
Senior MSAT Engineer
Location: Cork, Ireland (Hybrid working)
Duration: 12 months
Hours: 39
roles and responsibilities
The MSAT Engineer will be actively involved with the MSAT team to ensure the successful execution of all validation activities in alignment with Good Manufacturing Practices (GMP). The primary focus of the role will be on Cleaning Validation, including the planning, documentation, and execution of cleaning validation studies. The engineer will also lead or provide technical guidance on cleaning and process improvement projects and investigations. In addition to these core responsibilities, the role will also involve secondary activities such as Thermal Validation, Process Support Validation, support for process improvement initiatives, and participation in New Product Introduction (NPI) and process validation efforts. The role includes the generation of GMP documentation such as protocols, standard operating procedures (SOPs), work instructions (WIs), technical documents, and exception/event investigations.
This will include:
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 Large Molecule manufacturing industry or equivalent.
Focus on patients and customers at all times.
Key Skills and Proficiencies Required:
Excellent interpersonal skills.
The ability to operate as part of a team is essential.
Proven leadership skills and critical thinking ability.
Excellent communication skills both written and verbal.
Attention to detail.
Innovative with great problem-solving skills.
Results and performance driven.
Adaptable and flexible.
Integrity, trustworthiness and objectivity.
Knowledgeable of FDA/EMEA regulatory requirements.
Desirable:
Experience in Cleaning validation studies and Cleaning strategy (Minimum 2 years).
Also, beneficial would be experience in Thermal 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 a 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.
Familiarity with FDA/EMEA regulatory requirements for biologics and/or pharmaceuticals.
Knowledge of stability data trending and protein stability is an advantage.
Ability to thrive in a fast-paced, diverse team environment, with a strong focus on attention to detail and maintaining a high level of quality and integrity in all aspects of the role.
Benefits
This role offers a very competitive hourly rate. This contract will run for a minimum of 12 months with a review for a potential extension.
you are welcome here
Johnson & Johnson 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.
https://innovativemedicine.jnj.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 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”.