JOB DESCRIPTION

Job Title: Serialisation Engineer

POSITION SUMMARY:

• To act as the site Engineering SME for serialisation.
• Take ownership for the site serialisation requirements and support site training for serialisation.
• Support internal and external issues related to serialisation, supporting investigations and file repair activities. Responsibilities will include responding to serialisation system/equipment raised support requests on the packaging lines.
• Develop equipment recipes for production inclusive of recipe entry on serialisation packaging equipment based on provided master data, label layouts and client requirements, Provide support on onboarding, Master Data and connectivity serialisation activities with current and future partners.
• Function as a site Tracelink track and trace system administrator!
• Support Codesoft label development (Packaging Engineering Support for Line Test and Production).
• Retrieve supporting data from automation systems to support production or quality department requests.
• Participate in engineering and validation testing for serialisation connectivity activities.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

• HNC/HND, Engineering qualification and/or related subject area experience.
• Packaging experience essential (with serialisation systems desirable)
• Relevant experience within a Pharmaceutical/GMP environment, legislation and best document practices – highly desirable
• Experienced in analytical reporting required to undertake reconciliation to ensure customer requirements are met including technical writing.
• Strong analytical skills, relevant experience of reconciling reports against customer requirements.
• Proficient in Microsoft Office Suite (Word, Excel,etc) including experience of working with databases and XML files.

THE ROLE:

When you are part of Thermo Fisher Scientific, you will do challenging work, and as part of a team that values performance, quality, and innovation. As part of a successful, growing global organisation you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Fisher Clinical Services, part of Thermo Fisher Scientific, has an unwavering dedication to service, science and process engineering, Fisher Clinical Services is powered by people with an outstanding dedication to quality, deeply instilled ethics of personal responsibility and outstanding expertise. We are passionate about serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labelling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring alignment to the highest level of quality, performance, reliability and sustainability standards.

KEY RESPONSIBILITIES:

• Ensuring the process for products to be manufactured is set up and maintained in accordance with GMP, Standard Operating Procedures and other regulatory agency requirements.
• Complete & handle updates to serialisation system SOPs, to align with current local and global serialisation procedures
• Requires excellent organisational, planning, verbal, written and numerical skills with the capability to analyse and define solutions and prioritise multiple tasks to meet agreed timelines.
• Requires strong and effective communication with the ability to effectively present information and respond to serialisation questions from groups of managers and clients.
• Requires ability to build strong customer relationships; proactively anticipates, understands, and responds to the needs of clients to meet or exceed their expectations
• Ability to learn and master all internal systems associated with projects (i.e. Tracelink, Codesoft, Trackwise, EDMS).
• Work in a safe and responsible manner to build an injury-free and incident-free workplace.
• Have a continuous improvement mentality, aid projects including process improvements to reduce cost, improve efficiency and Quality.
• Align with all job-related safety and other training requirements.
• Participates in weekly site and distributed team meetings.
• Carry out other duties as assigned to support the engineering department including general maintenance activities (PPMs), and machine breakdown response.