Manufacturing Process Specialist

9 hours ago

Cork, Ireland CPL Full time

Kenny-Whelan (a specialist division of the CPL group) are recruiting 2 x Manufacturing Process Specialists to work on the Material Supply Optimization Team at Janssen Sciences in Ringaskiddy

Level 8+ Degree essential

Not a production operator/Light Industrial role.

Contact Jenn Dinan on 0214665408 or email your CV to [email protected]

MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it

Reporting to Manufacturing Readiness Manager, this position is responsible for evaluation dual source alternatives for single use materials such as filters, bags, assemblies, and tubing to determine suitability for introduction to Janssen Cork These activities include but are not confined to:

General Activities

· Generating technical drawings for alternative material design proposals by second source suppliers

- Evaluating current material usage and suitability testing of proposed material alternatives

· Presenting to Change Control Board and raising of Change Controls for materials determined as suitable alternative for current materials

· Updating and compiling material documentation and data to support review and implementation process

· Attending daily team and departmental meetings

· Communicating with various departments for material scoping and implementation of alternative material

· Liaising with vendors and the wider members of the Cork Bio site to obtain relevant information for the completion of change controls.

· Investigation and resolving issues associated with change controls.

· Liaising with procurement, Material Sciences and Technical Operations to ensure all technical requirements for new components have been met.

· Updating recipes with Filter Integrity Requirements for new filters as required

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 Manufacturing Readiness 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.
- Prioritise 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 pertaining to single use material concerns.
- 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
- Evaluate and strategize shelf life extensions for single-use consumables, optimizing material usage.
- Work closely with QA to maintain product integrity within extended shelf life parameters.
- Own and manage Quality records.
- Follow up with assessors and hold meetings if required.

LEADERSHIP RESPONSIBILITIES / INDIVIDUAL CONTRIBUTION

· Report to Manufacturing Readiness Manager.

· Represent the Cork BOOST Team 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.

QUALIFICATIONS AND EXPERIENCE:

ESSENTIAL:

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

DESIRABLE:

· Manufacturing experience within a GMP regulated environment.

· Project / New equipment installation experience

· Process engineering experience

· Commissioning and qualification experience

· Postgraduate Qualification.

· Experience of Microsoft Word, Excel and Outlook.

· Experience of SAP, electronic documentation system and/or other business systems.

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

All applications will be treated with the strictest of confidence

Please apply via the link or email your CV directly to [email protected]

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