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ERF CertRP | Talent Solutions Specialist | Sourcing & Developing Life Sciences Talent @ Tandem Project Management
Summary:
Our client, a biopharmaceutical company based in Dublin, is seeking a Senior Process Engineer (Upstream) to join their team. The successful candidate will lead, assist with, and facilitate investigations, ensuring effective root cause analysis and CAPAs, as well as data analysis and interpretation to resolve complex cell culture deviations.
Responsibilities:
* Lead process improvement and troubleshooting with end-to-end product focus.
* Support the industry 4.0 initiative to navigate operations and data analytics in a digital environment.
* Provide technical support to new process introduction or change implementation in commercial manufacturing operations.
* Author and review batch documentation, technical reports and supporting global regulatory submissions as needed.
* Provide technical guidance to members of the process engineering team.
* Support execution, data analysis and interpretation of trends observed in commercial process monitoring (e.g., proactive process analysis, continued process verification, statistical process control, multivariate analyses).
* Lead and/or support various site initiatives to improve compliance status and overall operational efficiency of the site.
* Lead and/or support the execution of development and PPQ batches.
* Resolve issues and identify risks in a timely fashion.
* Ensure project milestones are achieved through planning and execution of integrated overall program schedule.
Qualifications & Experience:
* Degree (or higher) in science, engineering, technical discipline, or equivalent.
* Minimum of 6 years in operational support, or 4 years with technical support, within the biopharma industry, including direct experience in USP (Upstream) biologics manufacturing, facility commissioning, qualification, validation, and start-up.
* Extensive experience in upstream processing and troubleshooting, including tech transfer, regulatory filings, and commercial manufacturing.
* Proven experience in leading complex investigations.
* Experience supporting regulatory inspections.
* Working knowledge of current regulatory requirements and Good Manufacturing Practices (cGMP).
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Industries
Pharmaceutical Manufacturing
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