Manufacturing Process Specialist

Manufacturing Process Specialist

Location: Barnahely, Cork

Working mode: Hybrid, 3 days per week on-site and 2 WFH

Duration: 12 months initially

Hours: 39 hours per week (8am/8:30am start)

Hourly rate: Competitive hourly rate (PAYE, Umbrella and Ltd options available)

Reporting to Operations Manager, this position is responsible for representing operations on capital  project teams and supporting first line troubleshooting of the day-to-day activities within Operations - These activities include but are not confined to: 

General Activities 

• Represent Operations on cross functional project implementation teams. 

• Monitoring and troubleshooting of the manufacturing process and equipment issues and process  optimization.

• Monitoring and reporting of process performance using statistical process control 

• Troubleshooting of DCS (e.g Delta V) and PLC control systems 

• Investigating and resolving issues raised within the Manufacturing Department 

• Participate in/ Lead Cross Functional teams when required. 

• Support of Commissioning and Qualification activities.

• Preparation and updating of Batch Records, Procedures and Work Instructions.

• Provide process and equipment related training as required within the Manufacturing Department.

• Completion of assigned tasks to support manufacture of quality biomedicines in accordance with  cGMP and EHS requirements. 

• Ensure that personal training requirements are completed in compliance with site procedures. 

• Training and support for new recruits to the Manufacturing group 

• Support ongoing studies by Validation, OTS, and other support functions

GENERAL SCOPE OF RESPONSIBILITIES:  

• Lead by example and strive to perform to high standards at all times. 

• Responsible and accountable for assuring the safe accomplishment of job activities, following  good environmental practices and procedures. Commit to and demonstrate safe behaviour in every  activity. 

• Carry out routine and non-routine tasks delegated by the Operations Manager according to  appropriate procedures, values, and standards. 

• Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.

• Compliance with Manufacturing and general site procedures at all times. 

• Completion of all documentation in compliance with site procedures and GDP.

• Execution of activities as necessary to meet operational and business needs. 

• Lead, support and participate in commissioning and qualification activities both current and  future projects (and annual re-qualification activities). Also support to validation activities.

• Prioritize and schedule activities to support business needs and to meet requirements of Master  Production Schedule. 

• Lead and Support investigation and resolution of problems on plant.  

• Participate in and lead Cross-Functional teams as necessary. 

• Generate and assist with generation, review, and revision of Manufacturing documentation as  necessary.  

LEADERSHIP RESPONSIBILITIES / INDIVIDUAL CONTRIBUTION 

• Report to Operations Manager. 

• Represent Operations on cross functional project teams. 

• Be familiar with daily activities in Manufacturing. 

• Facilitate an environment of continuous improvement. 

• Facilitate an environment of open communication. 

• Lead investigations in work area as necessary. 

• Lead Cross-Functional teams as necessary to support site goals. 

• Support training of other Manufacturing colleagues.  

• Collaboration and teamwork. 

• Initiative and motivation. 

• Share ideas and suggestions for improvement and encourage others to do the same. Demonstrate Credo value of integrity. 

ORGANISATIONAL INTERFACES: 

• Interface at (Team Leader, Manager and Director level) with all site departments, Operations and  Maintenance. 

• Contact with Engineering, Quality, Logistics, OTS, Validation and Training departments.

• Contact with  other Janssen Biologics sites. 

• Be conscious of internal customers to Manufacturing department and be cognoscente of their  requirements.

how to succeed

ESSENTIAL: 

• A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy,  Biotechnology, Science or Engineering 

DESIRABLE: 

• Manufacturing experience within a GMP regulated environment. 

• Experience of the cell culture or purification processes  

• Project / New equipment installation experience 

• Process engineering experience 

• Commissioning and qualification experience 

• Postgraduate Qualification. 

• Experience of Microsoft Word, Excel and Outlook. 

• Experience of DCS (e.g. Delta V), SCADA and PLC systems 

• Experience of SAP, LIM’s and/or other business systems. 

• 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.  

KEY COMPETENCIES REQUIRED: 

• Excellent interpersonal skills. 

• Ability to operate as part of a team is critical.  

• Customer focus. 

• Innovative. 

• Mechanical/Technical aptitude. 

• Excellent communication skills both written and verbal. 

• Attention to detail. 

• Good problem-solving skills. 

• Results and performance driven. 

• Adaptable and flexible.

benefits

This role offers a very competitive hourly rate. This contract will run initially for 12 months.

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.

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. 

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”.