The Validation Engineer will be essential in ensuring efficient and effective compliant design, construction, qualification, approval and operation of the new state-of-the-art facility in Dublin during the initial project phase. The successful candidate will take a lead on utilising the latest innovations in technology and automation to create a workplace of the future. Reporting through the site manufacturing and technology head and based at the Dublin site. Support the design, construction and qualification of the new facility and manufacturing science and technology laboratory.
• 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 company and 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 the company’s 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.
• Project validation support including conducting equipment performance qualifications (specifically cleaning and sterilization validation.)
• Authoring project validation master plans; SOP and documentation updates.
• Authoring validation protocols and final reports, executing validation studies, analysis of validation data.
• Resolving technical issues encountered during study execution.
• Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience.)
• Minimum of 3 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company.
• Engineering or scientific background.
• Equipment Validation and Sterilization Validation.
• 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.
• Partswasher and Autoclave Experience.
• Strong technical writing and oral communication skills.
• A working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• Strong contemporary knowledge.
• Demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviours.
• The ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
Purpose: The individual in this position implements policies and procedures to validate/qualify computer systems. Plans, coordinates, and participates in a...Apply For This Job
Purpose: An exciting opportunity has come for a Validation Engineer to join the Carlow Commercialisation team to transition from a...Apply For This Job
Purpose: An exciting opportunity has come to join the Commercialisation team to support the transition from a project phase to...Apply For This Job
Purpose: Managing and leading the QA Validation Oversight group who are responsible for the review and approval of Validation activities...Apply For This Job
Purpose: As part of a significant expansion of the site, an exciting opportunity has come for a Senior Validation Engineer...Apply For This Job