Manufacturing Process Specialist - Johnson & Johnson

About the Johnson & Johnson

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/.

Introduction and Overview

We are hiring for a Manufacturing Process Specialist.

This position is a member of the Operations Team with primary responsibility to produce Aseptic and Low Bioburden API.

This position provides technical operational support aseptic manufacturing.

We encourage and support the identification and development of innovative operational solutions and multi-functional teamwork throughout the Johnson & Johnson Global API Small Molecule Network.

This role has a large degree of scope and autonomy to improve production performance and reliability to improve human health by improving the first manufacturing step in changing patients lives for the better.

This position is located in Little Island, Cork and reports to the Senior Operations Manager.

Objectives of the Position


* As a core member of the business unit the Manufacturing Process Specialist is responsible for providing technical support to the business unit in ensuring efficient manufacturing while ensuring compliance with GMP, EHS standards at all times.


* Management of non-conformances (including customer complaints, EHS incidents, etc.) to ensure timely investigation, root cause analysis and implementation of corrective and preventive actions.


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


* 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.


* 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.

What you will need to succeed

We are looking for a dynamic, flexible, and team-oriented personality with a high level of customer orienta...