About Innovative Medicine
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We are searching for the best talents for the Manufacturing Process Specialist role to be in Cork, Ireland.
Purpose: The manufacturing process specialist will be responsible for representing operations on capital project teams and supporting first line troubleshooting of the day-to-day activities within operations.
As a Manufacturing Process Specialist, you will:
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.
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 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 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.
•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 / 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 cognisant of their requirements.
Qualifications / Requirements
•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.
Desirable
•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.
Significant Environmental, Health and Safety Considerations
All employees are required to comply with the requirements of the company's Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual. In line with the Safety Health & Welfare at Work Act (2005), all employees are required to:
•Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
•Comply with EHS rules and procedures at all times.
•Understand the potential EHS impact of their activities.
•Attend and participate in EHS training as required.
•Use PPE and safety equipment as required.
•Report all incidents, accidents, and near miss events.
Preferred Skills
Agile Manufacturing, Analytical Reasoning, Business Behavior, Communication, Continuous Improvement, Data Analysis, Design Thinking, Execution Focus, Good Manufacturing Practices (GMP), Innovation, Lean Manufacturing Principles, Manufacturing Engineering, Manufacturing Flow Management, Manufacturing Processes, Monitoring, Evaluation, and Learning (MEL), Plant Operations, Production Operations, Profit and Loss Responsibility, Sustainability.
Pay and Benefits
The anticipated base pay range for this position is €43,100.00 - €69,000.00.
In addition to base pay, benefits include: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and company's performance of the previous calendar year, or sales commissions. Also offered: vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health, service anniversary and recognition awards, and, subject to the terms of their respective plans, participation in several insurance plans.
