Job Description
Kenny-Whelan(a specialist division of the CPL group) are hiringan MSAT Engineer to theMSAT Validation team at Janssen Sciences in Ringaskiddy ContactJenn Dinanon or email MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it new role - October 2024 Position Title: MSAT Engineer (Technical Operations Specialist ) Department:Manufacturing Science and Technology (MSAT) Position Summary: Kenny-Whelana great opportunity for an MSAT Engineer to join theMSAT Validation team at Janssen 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). Main Duties 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. 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: Required: 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. 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. MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it All applications will be treated with the strictest of confidence. Contact Jenn Dinan on Skills: validation studies Process Validation Biopharma Benefits: Paid Holidays Parking Staff discount