Drug Process Operations Specialist-Shift
* Industry Pharma/Biotech/Clinical Research
* Work Experience 4-5 years
* City Meath
* State/Province Meath
* Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
An amazing opportunity has arisen for a ProcessOperations Specialist, to provide operational support for manufacturingoperations of Late Stage and Launch Pipeline products at our new state of theart single use biotechnology facility in Dunboyne, Ireland.
Reports to: Drug Substance Process Operations Lead
Shift Pattern: 24/7 shift
Requirements
Responsibilities:
* Reporting to the Process Operations Lead the OperationsSpecialist will support end-to end production operations for both Fed Batch andContinuous Manufacturing
* Lead/Guide team members within the Production Operationsteam
* Coach and develop colleagues within the Production team
* Support team on shift cycle and act as POC (point ofcontact) and POE (point of escalation) to ensure effective issue resolution
* Lead, facilitate and participate in cross-functionalteams to collaborate effectively to cover compliance topics.
* Responsible for monitoring operational performance,follow-up on any significant adverse trends for the identification andimplementation of operational optimization, and robustness improvementprojects.
* Ability to solve problems and take new perspectives onexisting solutions with a desire to continuously learn, improve and develop.
* A Change and QRA Champion within the organization andsite, to bring about new technologies, digitization, and identify opportunitiesto bring new ways of working.
* Lead complex process investigations on the productionfloor in support of deviation resolution.
* Use the extensive operational experience to mentor newmembers of staff in specific plant activities when required and as a key pointof contact for external groups
* Support team on 24/7 shift cycle and act as POC (point ofcontact) and POE (point of escalation) to ensure issue resolution
* Conduct all work activities with a strict adherence tothe safety and compliance culture on site
* Participate in safety, process and environmentalinvestigations. Review alert and action limits as needed and implementcorrective action as appropriate
* Write, review, and/or approve manufacturing documentation(SOPs, Manufacturing Records & Logbooks)
* Ensure the effective use of material, equipment andpersonnel in producing quality products.
Required Education, Experience and Skills:
* Bachelor’s degree in Biotechnology, Chemistry, Biology,Pharmacy, or Process engineering.
* 4 years + experience in Biotech Industry (bulkmanufacturing of pharmaceutical or biological components). Position level will scale withexperience level of candidate.
* Competent in analyzing complex situations and showpractical problem-solving capabilities.
* Ability to work independently and within across-functional team.
* Understanding of multi column chromatography concepts
* Familiarity with contamination control and batch releaserequirements
* Experience leading, presenting, or supporting RegulatoryInspections and Site Internal Audits
* Problem, Deviation, and Change Management experience
Preferred Experience and Skills:
* Commissioning and Qualification experience
* Understanding of Upstream and Downstream Unit Operationsfor mAb manufacturing
* Familiarity with Emerson DeltaV, SIPAT,and the use of Automation in amanufacturing Process.
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