US-MA, Senior Validation Engineer II SR0030424-MZ
The person in this role will be instrumental in working with other members of the Quality, Manufacturing and Engineering organizations to develop and execute the validation studies and projects to enhance the manufacturing systems and processes to compliantly and efficiently achieve organizational goals. Responsibilities Job Function and Description Varies, 30-80% Write, execute, summarize validation activities in the following areas: Computer Systems Plant Automation Validation Maintenance Validation document control and archival program Tech Transfer Develop and assess the following Quality System elements for Validation: Quality Risk Management program CAPAs Change Controls Deviations GMP Investigations Participate and contribute in design, development, validation strategy, and routine GMP activities: Provide technical input to strategy/philosophy for validation activities Represent validation during tech transfer activities as required. Represent validation during site GMP activities and participate on cross-functional teams On-going Identify opportunities for continuous improvements, participate in the deployment of best practices, pro-actively update validation programs to reflect current regulations and trends. Varies, 10 - 20% Participate in partner audits and regulatory agency inspections for Validation. Author and review sections of regulatory filings and annual product quality reviews. Train other Takeda staff on validation equipment and protocols Education and Experience Requirements Minimum requirements include a Bachelor's degree in a technical discipline, preferably engineering or biological sciences and a minimum of 10 years pharmaceutical and/or biopharmaceutical industry experience. An advanced degree (masters) or industry certification is a plus. Key Skills, Abilities, and Competencies Qualified candidates will have: Experience in executing and reviewing validation studies. Experience in executing tech transfers, capital projects Familiarity with Operational Excellence concepts Participation in complex validation projects and cross-functional teams Knowledge of global cGMP requirements and expectations (US, EU, Japan, ICH, PIC/S, WHO) as they pertain to validation. A desire and skill to work as a team member and to work with others to ensure coordinated goals are achieved Exemplifies trust and openness and a willingness to partner with others. Willingness to receive and listen to feedback. Ability to work in a fast paced environment and ability to manage multiple projects and priorities.
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