Mto Technical Writer - Manufacturing Specialist Venezia

Mto Technical Writer - Manufacturing Specialist
Venezia
Veneto, Venezia

Our client, one of the largest multinational companies in the US, is looking for a Technical Writer - Manufacturing Specialist in Severn, MD 21077, United States. JOB TITLE: Technical Writer - Manufacturing SpecialistLOCATION: Severn, MD 21077DURATION: 12+ MonthsJob Description:The Manufacturing Technical Specialist will provide support for Manufacturing Management and Associates to meet batch record review/disposition schedules 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 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 are a must to be successful in this role!The Role:Initiates Quality Records and conducts deviation investigations that meet both Industry and Catalent expectations. Leads or manages investigations including root cause analysis and assesses product impact using input from various departments. Develops, executes, and oversees CAPAs. Provides technical leadership 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. Revises and manages 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:Bachelor's 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.

#J-18808-Ljbffr