Senior MSAT Engineer - Ireland - Johnson & Johnson

Description

Description

Company Summary:

Janssen Sciences Ireland UC, is part of the Johnson & Johnson family of companies, the world's most comprehensive and broadly-based manufacturer of healthcare products and related services. Our site in Ringaskiddy was established in 2005 on a 100-acre site with an investment of €500 million. In 2017, we invested a further €300 million in the expansion of our manufacturing plant and created 200 additional jobs. We manufacture a range of biopharmaceutical products indicated for the treatment of conditions that include rheumatoid arthritis, psoriasis and cancer.

Position Summary:

We have a great opportunity for a Senior MSAT Engineer to join our Life Cycle Management (LCM) Team at the Ringaskiddy site.

The Senior MSAT Engineer is an integral member of the MSAT team, delivering successful outcomes to all MSAT activities. Primary activities are in the area of Life Cycle Process Validation, 2nd line technical support to operations, process improvement, New Product Introduction (NPI) and new technology deployment.

Main duties and responsibilities:

• Providing detailed SME technical knowledge, in a 2nd line support role to Manufacturing Operations, with particular focus on commercial products.
• Acting as site Technical Owner of commercial products on the Cork site, leading and coordinating any changes to products, and supporting technical discussions related to the manufacture of products
• Leading and /or providing technical guidance into process improvement projects, commercial product scale up projects and NPI
• Championing the roll out of new technology to improve our processes
• Coordinating and driving LCM activities (Process Qualification and Continued Process Verification)
• Representing the Cork MSAT site team on LCM platform technical teams
• Preparing, reviewing, and approving technical documents, CAPAs, change control, deviations, and metrics.
• Leading complex multi-functional investigations
• Providing technical support / direct participation as technical SME in partnership with Quality and Operations for regulatory audits and inspections
• Participate in multi-functional teams as required.
• Conduct activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements.

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.
• 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 Science or Engineering is required.
• At least 3 yrs experience in the Large Molecule manufacturing industry or equivalent.
• Focus on patients and customers at all times.
• Strong expertise in Bio-pharmaceutical manufacturing (Large Molecule API) processes and equipment.
• Process excellence (6sigma), lean concepts and statistical skills
• Ability to lead multi-functional team and to manage complexity and change
• Ability to interact at different levels of the organization and handle conflicting interests
• Ability to work independently under general direction, having a good sense of prioritization of goals and good time management
• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

Primary Location Primary Location

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