MSAT Senior Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Ringaskiddy, Cork, Ireland

Job Description:

We have a great opportunity for a Senior MSAT Engineer to join our MSAT Validation team.

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 / the particular project schedule.
• 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.
• Interact at different levels of the Organisation, site and global.
• Drives for innovation and change to ensure competitiveness.

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.
• Can-do mentality, agility & flexibility to work with stretch goals and deadlines.
• 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 3 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 Thermal Validation, Cleaning 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.