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Job Description
MSAT Engineer required for the MSAT Validation team at Janssen Sciences in Ringaskiddy, Ireland. The successful candidate will be responsible for conducting MSAT activities in compliance with US and EU regulations, developing MSAT documentation, and leading process improvement projects.
Key Responsibilities:
- Conduct MSAT activities in compliance with US and EU regulations, JSI procedures, and EHS&S requirements.
- Develop MSAT documentation (strategies, plans, protocols, procedures, reports) and co-ordinate MSAT document review and approval.
- 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.
- Represent 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.
Requirements:
- A minimum of a Degree in Engineering, Molecular Biology, Biochemistry, Pharmacy, or related scientific field.
- At least 2 years of experience in the Large Molecule manufacturing industry or equivalent.
- Excellent interpersonal skills.
- Ability to operate as part of a team.
- 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.