Job Description
This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description When you are part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clients across the world. Whether planning, packaging, labeling, storing, or distributing important supplies, Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com/ Location/Division Specific Information CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters. How will you make an impact? As part of our team, what you do contributes directly to our mission, enabling our customers to make the world healthier, cleaner and safer. What will you do? The Team Leader, Technical Operations is responsible for identifying equipment/process problems and improvement opportunities in the primary and secondary packaging operations. This role requires mechanical proficiency, diagnostic and problem-solving abilities, strong technical writing skills, and the ability to communicate both verbally and written. The individual will work independently and provide leadership to the Technical Operators and be the Subject Matter Expert (SME) on all equipment in packaging. They will work closely with Packaging Management to ensure efficiency and improvements are achieved on the equipment/process. They will create/update Change Controls, Deviation Investigations and SOPs for improvements, audit observations, corrective and preventative actions, and to maintain compliance with periodic reviews. They assist in problem solving and long-term continuous improvements with the Operations team, Engineering, Quality Assurance, and Information Technology departments. How will you get here? Education High School Diploma or GED, with a minimum of 6 years prior mechanical and process equipment experience in a GxP production environment. Associate or bachelor's degree preferred. Responsibilities Supervise up to 10 employees working on multiple production lines in a clinical pharmaceutical manufacturing/packaging environment. Apply Good Manufacturing Principles in all areas of responsibility. Remain informed about business deliverables and priorities and create staff schedule to support setup, repair, predictive and preventative maintenance among other activities. Monitor equipment trends. Ensure adequate coverage and response in an environment where priorities may change. Troubleshoot equipment setups and repairs as first frontline SME. Write equipment procedures (SOPs). Write investigations pertaining to equipment process and failures. Review equipment documentation. Performs new equipment Preventive Assessments. Maintain equipment and components inventory quantities. Responsible for process improvement and risk assessments regarding equipment processes. Responsible for supporting Operations staff on de