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Details
Process Operations Specialist
Reference: | AS23487 | Location: |
Meath |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Manufacturing and Technology Manager, Manufacturing Coordinator, Manufacturing Executive
We’re currently recruiting for an exciting opportunity with a Pharmaceutical organisation based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are addressing some of the world’s most challenging healthcare needs.support end-to end production operations for both Fed Batch and Continuous Manufacturing.
Duties:
- Lead/Guide team members within the Production Operations team
- Coach and develop colleagues within the Production team
- Support team on shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure effective issue resolution
- Lead, facilitate and participate in cross-functional teams to collaborate effectively to cover compliance topics.
- Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.
- Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
- A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
- Lead complex process investigations on the production floor in support of deviation resolution.
- Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups.
- Support team on 24/7 shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure issue resolution
- Conduct all work activities with a strict adherence to the safety and compliance culture on site
- Participate in safety, process and environmental investigations. Review alert and action limits as needed and implement corrective action as appropriate
- Write, review, and/or approve manufacturing documentation (SOPs, Manufacturing Records & Logbooks)
- Ensure the effective use of material, equipment and personnel in producing quality products.
- Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
- 4 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).
- Understanding of multi column chromatography concepts.
- Familiarity with contamination control and batch release requirements.
- Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits.
- Problem, Deviation, and Change Management experience.
- Commissioning and Qualification experience .
- Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
- Familiarity with Emerson DeltaV, SIPAT, and the use of Automation in a manufacturing Process.
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Pharmaceutical | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2012 Life Science Recruitment Ltd
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Pharmaceutical | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy visit Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 |
Web Design / SEO by WebScience | Valid XHTML - CSS







