The Senior Validation Engineer (SVR) will be responsible for the process validation of new drug products processes/equipment to the Athlone facility, and will manage and provide oversight of validation of equipment and systems at the Alexion Athlone Manufacturing Facility (AAMF). This role will be primarily focused on the validation ownership of all equipment on site. The SVE will develop and implement a robust validation program in line with best industry practice and current regulatory expectations and will also manage an ongoing requalification, periodic review and continuous process verification programs to ensure that all GMP manufacturing processes are maintained in a validated state and in control.
+ Leading and Managing projects for the validation equipment, processes and products to meet all safety, quality, regulatory and operational requirements.
+ Leading cross functional teams as part of project planning and deployment including collaboration with Quality, Safety, Operations, Facilities and Engineering, Supply Chain and Regulatory Affairs
+ Process mapping and gap analysis.
+ Review of equipment specification/design/procurement/installation and validation.
+ Project planning and execution including scheduling, task management, milestone planning and reporting.
+ Delivering projects on time and on budget.
+ Generation, review and approval of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
+ Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQOQ etc),
+ To facilitate and participate in meetings and workshops as part of Continuous Improvement activities.
+ To approve plant SOPs and other documents as required, ensuring the acceptability of content and format.
+ Maintain the Site Validation Master Plan (VMP) and associated Project VMP’s, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency.
+ Accountable for compliance via documentation completion, risk assessments, review of protocols and reports, closing out preventative and corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
+ Ownership accountability for execution of the sites Periodic Review and Re-qualification schedules.
+ Support and liaise with Technical Services in relation to the tech transfer of products into the facility.
+ Manage and perform data analysis and lead/support investigations as required and support the team to make informed decisions/recommendations around conclusions reached from data analysis, using appropriate methodologies as required.
+ Responsible for authoring portions of regulatory submissions and defending the commissioning, design and qualification of GMP equipment to regulatory agency representatives during inspections.
+ Site audit facing validation SME
+ Work collaboratively to lead a safe and compliant culture in Alexion
+ Minimum of 8 years’ experience in a cGMP biopharmaceutical or aseptic filling environment.
+ Must have direct experience performing equipment, utility, and/or computer system qualifications studies in a cGMP aseptic filling environment.
+ Strong validation knowledge equipment of such as Autoclaves, Sterile Filler, Depyrogenation Tunnels, Vial Wash, VHP Isolator and HEPA systems.
+ Must have direct experience of performing validation studies of thermal sterilization processes including Autoclave validation, Steam in Place (SIP) validation, and validation of depyrogenation processes.
+ Experience of supervising personnel is required as this role will have direct reports
+ Must have experience managing complex, multifunctional projects.
+ Experience in HPRA/FDA environment is required.
+ Strong technical writing and communication skills
+ Problem solving and Project Management skills essential.
+ Must be goal-oriented and able to prioritize and manage tasks
+ Bachelor’s degree required as a minimum; eight or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.