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Job Description
MSAT Engineer required for MSAT Validation team at Janssen Sciences in Ringaskiddy, Ireland.
Kenny-Whelan, a specialist division of the CPL group, is seeking a highly skilled MSAT Engineer to join their team. The successful candidate will be responsible for delivering successful outcomes to MSAT validation activities using Good Manufacturing Practices (GMP).
Key Responsibilities:
- Active engagement with the MSAT team to deliver successful outcomes to MSAT validation activities.
- Planning, documenting, and performing validation studies in the Process Validation Support area.
- Leading and/or providing technical guidance for process improvement projects and investigations.
- Secondary activities include Thermal Validation, Cleaning Validation, Supporting process improvement projects, and GMP documentation generation.
Main Duties and Responsibilities:
- Conduct MSAT activities in compliance with US and EU regulations, JSI procedures, and EHS&S requirements.
- Develop MSAT documentation 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.
- 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 an MSAT Engineer.
- Participate in multi-functional teams (project, investigations) as required.
Key Skills and Proficiencies Required:
- Excellent interpersonal skills.
- 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.
Education and Experience:
- A minimum of a Degree in Engineering, Molecular Biology, Biochemistry, Pharmacy, or related scientific field is required.
- At least 2 years experience in the Large Molecule manufacturing industry or equivalent.
- Focus on patients and customers at all times.
Desirable:
- Experience in Process Support studies, Thermal Validation, Cleaning Validation, and Process Validation.
- 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 teams and to manage complexity and change.
- Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA, and other authorities.