Manufacturing Process Specialist - Aseptic Processing

MANUFACTURING PROCESS SPECIALIST (ASEPTIC PROCESSING)

Location: Little Island, Cork

Duration: 12 Months

Hours: 39 hours per week, onsite

Imagine your next project driving technical excellence in a world-class aseptic manufacturing environment.

At Johnson & Johnson Innovative Medicine, we are led by our science and the patients who inform and inspire us. This role is a critical backfill within our business unit, ensuring we maintain the highest standards of production efficiency and compliance.

roles and responsibilities.

As a core member of the business unit, you will provide essential technical support to ensure efficient manufacturing while maintaining strict adherence to GMP and EHS standards.

This will involve:

• Development of new and revised manufacturing and cleaning recipes in line with Master Batch book requirements.

• Development of and subsequent reporting on metrics relating the overall end to end performance of the business unit including the preparation of scorecards, dashboard and data for management review.

• Management of investigations (including customer complaints, EHS incidents, NCPs etc.) to ensure timely investigation, root cause analysis and implementation of corrective and preventive actions.

• Management of the manufacturing related aspects of the Change Control system in line with site procedures.

• To participate in HAZOP studies so that potential problems are identified and designed out of processes.

• Identification of opportunities for improvement within the manufacturing process through trend analysis and continuous review of all operations (e.g. completion of Self Inspections/ Internal Audits/process Optimization).

• Partnering with business unit personnel in the proactive identification of innovative solutions to problems.

• Develop re processing /rework strategies, test methods and protocols.

• Attendance at operations meetings as required in support of the Business Units.

how to succeed.

You are a technical expert with a deep understanding of aseptic processing and a commitment to operational excellence. You thrive in a collaborative environment and possess the analytical skills to drive continuous improvement.

You will also bring:

• A third-level qualification in a relevant scientific or engineering field.

• Minimum of 5 years of experience within a pharmaceutical or GMP supervised Operations environment.

• Possesses knowledge and experience of Aseptic Manufacturing Processes and Annex 1 requirements.

• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.

• Proven experience within a GMP manufacturing environment, specifically in aseptic processing.

• Strong expertise in root cause analysis and investigation management (NCPs, EHS).

Experience with Change Control systems and HAZOP studies.

• The ability to work onsite at our Little Island facility.

details

This role offers a very competitive hourly rate. This contract will run for 12 months. It is an on-site position, full time. 

you are welcome here

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

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen Ireland: https://www.janssen.com/ireland/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) 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 each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.