Our client, one of the Largest multinational Company in the US is looking for a Technical Writer - Manufacturing Specialist in Severn MD 21077 United States location. JOB TITLE: Technical Writer - Manufacturing Specialist LOCATION: Severn MD 21077 Duration: 12+ Months Job Description: The Manufacturing Technical Specialist will provide support for Manufacturing Management and Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Manufacturing Technical Specialist will be responsible for, executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records. The Manufacturing Technical Specialist role is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role! The Role • Initiates Quality Records and conducts deviation investigations that meeting both Industry and Catalent expectations • Leads or manage investigations including root cause analysis and assesses product impact using input from various departments • Develops, executes and oversees CAPAs • Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective. • Supports Tech transfer and process monitoring support as needed • Works with the team to monitor critical process parameters • Revision and management of manufacturing documents such as Batch Records and SOPs • Leads or supports Continuous Improvement projects • Conducts data gathering, trending, and data presentation as needed to support investigations • Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report. The Candidate • Bachelors degree in a science or engineering field and 4+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field) • Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment • 3+ years of experience in process deviation investigations and remediation • Ability to perform interviews and familiarity with root cause analysis • Previous experience authoring and/or revising technical documents • Ability to support and/or lead system troubleshooting efforts Key leadership attributes: • Leads with Integrity and Respect • Delivers Results • Demonstrates Business Acumen • Fosters Collaboration and Teamwork • Champions Change • Engages and Inspires • Coaches and Develops Why Work for Us Here at Experis, We care about people and the role of work in their lives. We respect people as individuals, trusting them, supporting them, and enabling them to achieve their aims in work and in life. We have been recognized in multiple ways for our ability to do this successfully if you are interested in working with us and learning more about this opportunity, Click the apply button now and start the path of a new adventure ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.