Job Title: Manufacturing Process Specialist
Role Summary:
We are seeking a highly skilled Manufacturing Process Specialist to join our operations team in Cork, Ireland. The ideal candidate will have a strong background in manufacturing and be proficient in ensuring all processes comply with industry regulations and standards.
Key Responsibilities:
* Represent Operations on cross-functional project implementation teams.
* Monitor and troubleshoot the manufacturing process and equipment issues and process optimization.
* Monitor and report process performance using statistical process control.
* Troubleshoot DCS (e.g., Delta V) and PLC control systems.
* Prepare and update Batch Records, Procedures, and Work Instructions.
* Provide process and equipment-related training as required within the Manufacturing Department.
* Complete assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
Leadership Responsibilities:
* Be familiar with daily activities in manufacturing.
* Facilitate an environment of continuous improvement and open communication.
* Lead investigations in work areas as necessary.
* Collaboration and teamwork.
* Initiative and motivation.
* Share ideas and suggestions for improvement and encourage others to do the same.
* Interface with all site departments, Operations, and Maintenance.
* Contact with Engineering, Quality, Logistics, OTS, Validation, and Training departments.
Qualifications:
* Minimum bachelor's degree in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering.
* 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.
* 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.
* Ability to operate as part of a team with attention to detail.
About Us:
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. We offer a dynamic and inspiring working environment, opportunities to work on challenging projects and assignments, and possibilities for further personal and professional development/education.
What We Offer:
* Opportunity to be part of a global market leader.
* Dynamic and inspiring working environment.
* Opportunities to work on challenging projects and assignments.
* Possibilities for further personal and professional development/education.
* Excellent Benefits (Pension, Healthcare, Bonus, Onsite Gym among others).