Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

IRL - Manufacturing Process Specialist

Posted Jan 18, 2021
Job ID: JJJP00005525
Location
Cork , County Cork
Duration
1 year
(Feb 8, 2021 - Feb 6, 2022)
Hours/week
39 hrs/week
Payrate range
25 - 32 €/hr

Reporting to Operations Manager, this position is responsible for first line trouble-shooting of the day to day activities within Operations.


Responsibilities: 


  • Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization
  • Monitoring and reporting of process performance using statistical process control
  • Generation of data and reports to support Annual Product Reviews and Regulatory submissions
  • Troubleshooting of DCS (e.g Delta V) and PLC control systems
  • Investigating and resolving Deviations 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.
  • Working assigned shift patterns to meet business needs and manufacturing schedule.
  • Lead by example and strive to perform to high standards at all times
  • Responsible and accountable for ensuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behavior 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 requalification activities). Also support 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 the plant.
  • Participate in and lead Cross-Functional teams as necessary.
  • Generate and assist with generation, review and revision of Manufacturing documentation as necessary.
  • 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.


Leadership responsibilities:


  • Report to Operations Manager.
  • Be familiar with daily activities in Manufacturing
  • Facilitate an environment of continuous improvement
  • Facilitate an environment of open communication
  • Lead investigations in the 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



Qualifications and Experience:


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


Desirable:


  • Postgraduate Qualification.
  • Manufacturing experience within a GMP regulated environment.
  • Experience of Buffer or Media preparation or Equipment preparation in a manufacturing environment.
  • Experience of the cell culture or purification processes in either a manufacturing or a lab based environment.
  • 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:


  • 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.


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