Serialisation Engineer

• 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.

• 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.

• Confirmed self-starter with strong time management skills, able to work within a team as well as independently.
• Ability to empower, communicate and work within cross functional teams to deliver against critical project timelines in line with business need.
• Always Demonstrates the Thermo Fisher Core Competencies and 4i Values.
• Strong interpersonal skills (verbal and written).

• 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.

Thermo Fisher Scientific