Process Engineer/Technical Writer

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionAt 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 dedication to service, science and process engineering, we are powered by people with an exceptional dedication to quality, deeply instilled ethics of personal responsibility and outstanding expertise. We are passionate about serving the packaging and distribution requirements of clients across the world. Whether planning, packaging, labeling, storing, or distributing important supplies, we have been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards.Location/Division Specific InformationCTD 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 live by is "There is a Patient Waiting." Our outstanding 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.What will you do? Our company seeks a Technical Writer and Investigator, that investigates and responds to Quality Management System deviations and complaints to ensure root causes are identified and action plans are initiated to reduce the likelihood of recurrence. An ideal candidate has strong written and verbal communication to clearly and concisely enable Quality Assurance and clients to successfully analyze product impact.How will you get here?High school diploma and one year of experience working in a Pharmaceutical Packaging/GMP environment.Conducts all activities in a safe and efficient manner, applies Good Manufacturing Principles in all areas of responsibility, and demonstrates and promotes the company vision.Composes technical concepts in a clear and concise manner and assist prevention of reoccurrence. Investigates and responds to Quality Management System deviations and complaints. Conducts in-depth interviews to acquire and detail accurate information.Completes CAPAs and effectiveness checks. Establishes Quality recommendations for changes to Standard Operating Procedures and associated documentation.Knowledge, Skills, AbilitiesStrong written and verbal communication to convey technical concepts clearly and concisely with good punctuation and grammar to communicate and enable clients to effectively analyze product impact. Experience in Microsoft Suite (i.e. Excel, Word, PowerPoint). Ability to read and interpret GMP and other regulatory requirements. Proficiency in skills required to read, understand, and follow SOPs and policies of a GMP environment. Work accurately in a fast-paced environment. Define problems, collect data, establish facts, and draw valid conclusions. Apply Root Cause Analysis techniques to identify the root cause and critical contributing factors to the event. Work with subject matter owners to identify and detail the Corrective and Preventative actions that will minimize the risk of a repeat occurrence of the event.Engage internal contacts at all levels company-wide (IT, Quality Assurance, Operations, Client Services, Supply Chain, etc.). Must have the ability to present information and respond to questions from Quality Assurance, senior management, peers, and clients. Prioritization skills and strong dedication to timelines.Physical RequirementsPerform duties of position which include: Exert up to 10lbs of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Position may involve prolonged sitting but may involve walking or standing for brief periods of time. May need stoop, reach or bend.