Sr. Validation Engineer
4 weeks ago
Aseptic Processing Validation Sr. Engineer - Level 5 The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing. An exciting opportunity has arisen for a Sr. Engineer for the HVAC /AVS (Airflow Visualisation)/APS (Aseptic Process Simulation/media fill) Validation team within the Aseptic Process Validation team. The Aseptic Process Sterilisation team perform /validation/ re-qualification on equipment such as VHP isolators, autoclaves, CIP/SIP systems and Lyophilisers and provide validation oversight on aseptic processing simulations. This role will focus on managing the team responsible for HVAC requalification in the production environments, including managing the routine re-qualification program of airflow visualisation and filter integrity testing activities as well as testing in response to changes to the production environment. The activities of the Aseptic Processing Validation Sr. Engineer Support Operations from a Validation perspective to deliver and maintain equipment in a qualified state in the most efficient manner possible. Ensure Validation approach is based on the best available scientific evidence and professional judgment in collaboration with the Validation network. Develop and ensure internal policies, procedures and practices associated with maintenance of the Site Validation Master Plan and Requalification Plans specific to area of responsibility. Responsible for managing and co-ordinating the aseptic process simulation program, including aseptic intervention review, protocol and summary report review, MES hold time support. Responsible for supporting for airflow visualisation studies and HVAC requalification program. Collate and report on relevant validation data and metrics. Provide validation support for Amgen's quality management system, including change control, deviation and CAPA processes. Participate and deliver regulatory filings and RTQ's for validation. Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process. Work on moderately complex to complex problems, where analysis of situations or data requires in-depth evaluation of various factors. Strong judgment is required in resolving problems and making recommendations. Writes and/or implements, owns and approves changes to controlled documents (e.g., SOPs, Specifications, Master Protocols, etc.) as needed. Support senior leadership in creating and implementing mid to long- term plans for department. Demonstrate ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels. Ensure projects and routine work are executed safely, efficiently, and in accordance with all applicable codes and Amgen Standards. Review and approves protocols, reports and data tables generated by staff and contract personnel. Basic Qualifications: Master's degree with 5+ years of experience in validation, engineering Or BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality Preferred Qualifications: In-depth understanding and application of validation principles, concepts, practices, and standards. In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing Extensive working knowledge of sterilisation/decontamination systems and industry practices. Experience working with critical HVAC systems and qualification of AVS Experience with APS Demonstrate active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution Strong program and change management skills Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment Comfortable in a fast-paced, dynamic, and highly fluid company environment with works under consultative direction toward pre-determined long-range goals and objectives. Able to adjust workload based upon changing priorities Previous people management experience highly desired. Able to express ideas and present information effectively to Amgen leadership, within team functions, and with external partners Ability to think critically with demonstrated troubleshooting and analytical skills To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
-
Senior Validation Engineer
3 weeks ago
Dublin, Ireland Life Science Recruitment Ltd Full timeAseptic Processing Validation Engineer The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing. An exciting opportunity has arisen for a Sr. Engineer for the HVAC /AVS (Airflow...
-
Validation Engineer
4 weeks ago
Dublin, Ireland BMS Recruitment Full timeVALIDATION ENGINEER THIS ROLE PRESENTS AN EXCELLENT OPPORTUNITY TO WORK FOR A GROWING IRISH COMPANY SPECIALISING IN HVAC SERVICES IN CLEANROOMS IN THE MEDICAL, PHARMA AND BIOTECH SECTORS THE COMPANY: Established for 20 years, this company are a market leader in HVAC maintenance and cleanroom validation. They boast partnerships with some of the largest...
-
Dublin, Ireland Amazon Data Services Ireland Limited Full timeThe Data Center Construction Cost Control (CCC) team is part of a larger, highly creative and passionate team dedicated to deploying our continuously evolving Amazon data center facilities. As a Sr. Construction Cost Engineer, you will be responsible for providing cost support, guidance and recommendations to the Sub-Station project delivery team to ensure...
-
Validation Engineer
4 months ago
Dublin, Ireland West Pharmaceutical Services Full timeAt West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and...
-
Dublin, Ireland Amazon Web Services EMEA SARL (Irish Branch) - G50 Full timeAmazon Web Services is hiring a Sr. Product Design engineer for the Product engineering team. The product engineering team is a part of a global engineering team, responsible for the design and continuous innovation for products used within our rapidly expanding data center foot print. The Product Engineering team at Amazon works to design and develop...
-
Dublin, Ireland Bristol Myers Squibb Irl Full timeWorking with Us Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Sr Telecom Support Engineer, Chime SDK
6 months ago
Dublin, Ireland Amazon Data Services Ireland Limited - A65 Full timeDo you want to work on complex problems in the real time communications space while building Amazon's communications platform powered by Amazon Web Services (AWS)? Are you looking for a fast-paced AWS team to apply your deep analytical and engineering skills to? The Amazon Chime SDK team builds APIs and SDKs to deliver Real Time Collaboration as an...
-
Dublin, Ireland Amazon Data Services Ireland Limited - A65 Full timeAWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we’re the people who keep the cloud running. We support all AWS data centers and all of the servers, storage, networking, power, and cooling equipment that ensure our customers have continual access to the innovation they rely...
-
HVAC/Validation Technician
3 weeks ago
Dublin, Ireland Trescal LTD Full timeRole OverviewJoining our team as a Junior HVAC/Validation Technician you will be responsible for supporting our HVAC/Validation Engineers working in a range of commercial sites. You will assist with performing validation of HVAC Systems and associated Cleanrooms at prestigious client sites across Ireland.About the RoleAre you ready to start your career in...
-
Sr Associate Software Development Engineer
4 months ago
Dublin, Ireland Workday Limited Full timeAbout the Role We are looking for a passionate Sr Associate Software Development Engineer to join our Dublin Tools team and help us in our mission to guide the future direction of the Workday Developer Tooling ecosystem, so that it will better serve our community of users across Workday into the future. This role is for you if you are… Passionate...
-
Validation Specialist
6 months ago
Dublin, Ireland West Pharmaceutical Services Full timeWho We Are: At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of...
-
Sr. Lead-Cloud Engineer
6 months ago
Dublin, Ireland Northern Trust Corporation Full timeAbout Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world’s most successful individuals, families, and institutions by remaining true to our...
-
Associate Director of Validation
4 months ago
Dublin, Ireland Grifols Full timeThe Associate Director of Validation will lead and support the qualification and compliance readiness of our new global center for the warehousing, processing, packaging, and worldwide distribution of human blood plasma and plasma derivatives for therapeutic use. The Associate Director of Validation will be responsible for direct leadership over the...
-
Silicon Systems Validation Engineer
2 months ago
Dublin, Ireland Qorvo Full timeResponsibilities Debug faulty products, root-cause analysis, and defect reporting Work with cross-functional teams on the application of UWB in customer products Partner with project management and engineering leadership to develop lab characterization plans for UWB ICs Design test solutions for characterization of UWB ICs Identify test-gaps and...
-
HVAC/Validation Technician
3 weeks ago
Dublin, Ireland Trescal Ireland Full timeAbout the RoleAre you ready to start your career in Engineering with a leading global organisation?If so, we have an exciting new opportunity to become a Junior HVAC/Validation Technician at our site in Dublin, Ballymount. Job OpportunityJoining our team as a Junior HVAC/Validation Technician you will be responsible for supporting our HVAC/Validation...
-
Sr Manager Platform Engineering
2 weeks ago
Dublin, Ireland Pfizer Ireland Pharmaceuticals Full timeROLE SUMMARY The mission of the PGS Digital Creation Centre Team is to revolutionise processes and elevate experiences, propelling Pfizer Global Supply (PGS) towards exceptional outcomes. As the driving force behind the digital transformation of various operations including the shop floor, quality control, quality assurance, engineering, and environmental...
-
Sr. Manager
4 months ago
Dublin, Ireland Amgen Full timeSr. Manager - Security Accountabilities State briefly the principle objectives of the position:The successful candidate will fundamentally take local accountability for the protection of Amgen People, Assets, Information and Reputation in the Ireland and Netherlands Amgen sites / locations. They will lead, position, support, integrate and influence the...
-
Sr Director, Systems Design/Architecture Engineering
6 months ago
Dublin, Ireland Analog Devices Full timeRole title / Organization Affiliations: Sr. Director – Power Solutions / GBU Responsibilities: Direct Responsible Individuals (DRI) in GBU for driving power revenue growth Enable the global FAE community to identify and win more power businesses through tailored power solutions Partner with field-sales organization to develop customer engagement...
-
Manager/Sr. Manager, External Quality Planner
5 months ago
Dublin, Ireland BioMarin Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
-
Sr Software Engineer
1 month ago
Dublin, Ireland ServiceNow Full timeJob DescriptionDetails about Impact: ServiceNow Impact is a personalized value acceleration solution that lets customers realize the value of their ServiceNow investments. It provides AI-driven recommendations and ServiceNow expertise to validate the readiness of your organization to adopt ServiceNow AI innovations quickly, map investments to business...
