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Manufacturing Process Specialist

  • Job reference: 933654
  • Location: Cork City, Cork
  • Salary: EUR45000 - EUR55000 per annum
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 22/01/2021

Orion Group Life Sciences have an exciting opportunity for a Manufacturing Process Specialist for our Multinational Biopharmaceutical client based in the Cork area on an initial 12-month contract.

POSITION SUMMARY:
Reporting to Operations Manager, this position is responsible for first line trouble-shooting of the day to day activities within Operations - These activities include but are not confined to:

* 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.

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.
* 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.

QUALIFICATIONS AND EXPERIENCE

ESSENTIAL
* 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.


For more information on this role, call Dan on +353 868140295 daniel.ryan@orioneng.com for a completely confidential chat about this role and other opportunities


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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