Job DescriptionUse a focused, technical, problem solving approach to meet and exceed on functional and site goals and objectives.Act as an SME on activities involving the design, specification, selection, equipment performance, engineering CQV, technical drawings, vendor management, engineering assessment of changes, conducting and leading investigationsPull together cross functional teams to deliver on deviations, improvements and equipment changes that will move the production processes forward in the facilityPartake in specific manufacturing projects that arise on the process, equipment or systems providing a structured lean approach to problem resolutionResponsible for timely updates of site achievements and challenges.
A collaborative approach, working cross functionally on removing barriers to maintain a highly effective and productive self-directed team environment.As a key member of the start-up team on site play a key role in the commissioning and qualification activities on site, acting as a lead end user for systems as they transition across to the operations teams.
Ensure consistency between process design and technical SOPsEnsure all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times.Lead Best practice Aseptic Technique principles current with the GXP/ GMP guidelinesAttend Seminars on Aseptic technique principles ensuring compliance to current GMP guidelines.Provides significant contributions on project teams and may lead multi-functional teams on large multi-site project.Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.Report to management on a regular basis on performance and report any issues that need to be resolved.Foster compliance and schedule adherence to ensure the operational plan is achieved, includingMaximize the success rate for production operations by instituting programs to minimize failures.
Support strategic plans for plant improvements in order to increase efficiency and drive down costs.Communicate plant operational status regularly to management at the appropriate level of detail.
Communications will be both written documents, and in formal and informal oral presentations.Play a key role in developing process engineering related documents, technical SOPs, reviewing automation related functional design specifications and generating technical reportsStay abreast of current biotechnology and ATMP industry innovations, looking at ongoing optimizations of the single use technology, barrier technology and other innovations that could be employed on site.Act as a key SME for the introduction of new process equipment into the facility, and provide technical training or support for the operations based manufacturing personnel as equipment is brought on lineMaintain a high, and continuously improving, level of GMP compliance to ensure patient safety and to minimize risk to the company business.
Support Regulatory licensure activities, including agency inspections.
Requirements Bachelor's degree in a technical discipline (Science or Engineering)>5 years' experience in Aseptic filling operations and/or upstream biotechnology processes in a GMP environment.Experience with filling equipment and control approaches (e.g.
RABS and isolator) preferred.Should be knowledgeable of regulatory and GMP requirements.Proven ability around working cross functionally, delivering technical solutions and identifying improvements.Experience working in a self-managed work team, embracing an interdependent working culture that delivers resultsEnterprise mindset to ensure the right prioritizations take placeStrong project management skills.Strong stakeholder management skills to manage both internal and external stakeholders that support the site.A proven ability to get involved in cross functional teams and deliver on tight timelines.Excellent influencing/collaboration skills and teamwork mindset.Excellent trouble shooting and problem-solving skillsPromoting a culture where diversity and inclusion is part of the DNA of the sitePackageExcellent benefits packagePerformance Related BonusHealth InsurancePensionFlexibility Paid Maternity/Paternity LeaveEducational Assistance ProgrammeZero Absence AwardTalent & Development ProgrammeOccupational Health & Wellness Programme