Upstream Manufacturing Technology Engineer
- Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings.
- Investigation and resolution of process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings.
- Strong knowledge of cGMP compliance, site and regulatory agency requirements.
- Assists in evaluating process performance by comparing manufacturing data to historical data from other sites.
- Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
- Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
- Minimum BSc or equivalent with at least 4 years’ experience in cell culture or purification manufacturing technical support in the biopharmaceutical industry including experience with process validation.
- You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
- Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
- You have proven problem solving ability, project management skills, including leading cross functional teams and balancing multiple project assignments.
The candidate must have the rights to work in the location stated in the job advert.
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Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for an Administrative Assistant
As Dublin continues to embed itself as Irelands Pharmaceutical capital, we are seeking Quality Specialist to become part of a $500 million state of the art bio facility. Located 15 minutes from
Bulk Drug Substance Manufacturing facility are in need of an experienced QA Validation Engineer who has knowledge of both Upstream & Dowstream processing to execute the site QA activities from
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