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 Validation Engineers to join their team in Dublin for their new large-scale facility.
This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.
Essential Duties and Responsibilities for this validation role include, but are not limited to, the following:
- Support the design, construction and qualification of the new facility and manufacturing science and technology laboratory by:
- Developing and maintaining the site Validation Master Plan.
- Driving completion of cleaning and sterilization cycle validation activities.
- Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and revalidation.
- Develop post OQ documentation in line with regulatory requirements.
- Authoring and reviewing standard operating procedures and technical reports.
- Supporting global regulatory submissions as needed.
- Applying LeanSixSigma in the Validation group by:
- Securing continuity of an appropriate LSS/CEM level of knowledge.
- Facilitate problem solving & risk assessment (FMEA) projects/meetings.
- Making problems visible and strive for continuous improvement.
- Serving as a key member during internal audits and external inspections/audits.
- Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
- Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
- Represent the site in internal collaborations through MMD Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
- Keep up to date with scientific and technical developments.
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
- Experience with upstream cell culture and/or downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
- Technical operations experience in the drug substance manufacture of biological molecules at the pilot- and/or commercial-scale.
- Prior experience in drug substance , process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
- Temperature Mapping Experience.
- Cleaning Validation Experience.
- Autoclave Experience.
If this sounds of interest then please apply to find out more information!!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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