Only 24h Left Manufacturing Process Specialist

Job Description - Manufacturing Process Specialist (2506232529W)

Johnson & Johnson Innovative Medicine is currently seeking a Manufacturing Process Specialist to join our operations team located in Cork, Ireland.

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.

Are you proficient in ensuring all manufacturing processes comply with industry regulations and standards? Can you develop and manage a preventative maintenance schedule for all production equipment? Looking for a role where your attention to detail and skills make a difference? Then we have a position for you

What you will be doing:

The manufacturing process specialist will be responsible for representing operations on capital project teams and supporting first line troubleshooting of the day-to-day activities within operations.

General Activities:

1. Represent Operations on cross-functional project implementation teams.
2. Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization.
3. Monitoring and reporting of process performance using statistical process control.
4. Troubleshooting of DCS (e.g., Delta V) and PLC control systems.
5. Preparation and updating of Batch Records, Procedures, and Work Instructions.
6. Provide process and equipment related training as required within the Manufacturing Department.
7. Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.

General Scope of Responsibilities:

1. Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures.
2. Carry out routine and non-routine tasks delegated by the Operations Manager according to appropriate procedures, values, and standards.
3. Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
4. Compliance with Manufacturing and general site procedures at all times and completion of all documentation in compliance with site procedures and GDP.
5. Lead, support, and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities).
6. Lead and support investigation and resolution of problems on plant and participate in and lead Cross-Functional teams as necessary.
7. Generate and assist with generation, review, and revision of Manufacturing documentation as necessary.
8. Ensure that personal training requirements are completed in compliance with site procedures.
9. Support ongoing studies by Validation, OTS, and other support functions.

Leadership Responsibilities / Individual Contribution:

1. Be familiar with daily activities in manufacturing.
2. Facilitate an environment of continuous improvement and open communication.
3. Lead investigations in work area as necessary.
4. Collaboration and teamwork.
5. Initiative and motivation.
6. Share ideas and suggestions for improvement and encourage others to do the same.
7. Interface with all site departments, Operations, and Maintenance.
8. Contact with Engineering, Quality, Logistics, OTS, Validation, and Training departments.
9. Be conscious of internal customers to Manufacturing department and be cognizant of their requirements.

Qualifications

We would love to hear from YOU if you have the following essential requirements:

1. Minimum bachelor’s degree in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering.
2. Manufacturing experience within a GMP regulated environment.
3. Experience of the cell culture or purification processes.
4. Project/New equipment installation experience.
5. Process engineering experience.
6. Commissioning and qualification experience.
7. Experience of Microsoft Word, Excel, and Outlook.
8. Experience of DCS (e.g., Delta V), SCADA, and PLC systems.
9. Experience of SAP, LIM’s, and/or other business systems.
10. 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.
11. Ability to operate as part of a team with attention to detail.

What’s in it for YOU?

This is an opportunity to work with a ground-breaking medical device operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.

We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.

Whether you’re one of the 1000 people who work here, or you’re considering joining the team, we offer:

1. An opportunity to be part of a global market leader.
2. A dynamic and inspiring working environment.
3. Opportunities to work on challenging projects and assignments.
4. Possibilities for further personal and professional development/education.
5. Excellent Benefits (Pension, Healthcare, Bonus, Onsite Gym among others).

What type of mark will YOU make?

By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well as your mind. When you work with us you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson & Johnson means "YOU belong"

For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued, and every one of our people feels that they belong and can reach their potential. No matter who they are.

Significant Safety or Working Considerations:

All employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation, and duties outlined in the site EHS Manual.

In line with the Safety Health & Welfare at Work Act (2005), all employees are required to:

- Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
- Comply with EHS rules and procedures at all times.
- Understand the potential EHS impact of their activities.
- Attend and participate in EHS training as required.
- Use PPE and safety equipment as required.
- Report all incidents, accidents, and near miss events.

IMPORTANT

This position description is a general guideline for colleagues, it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling, or other business needs.

Primary Location

Europe/Middle East/Africa-Ireland-Cork-Cork

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our page for information on how to request an accommodation.

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