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Technical leadership and/or support of GMP processes, process analysis and process equipment:. Having a customer service mindset to provide technical leadership supporting manufacturing operations with the appropriate sense of urgency... Provide technical leadership to support process tech transfers and/or expense/capital projects through budget development, schedule development, resource planning, design, construction, commissioning and qualification activities; with the ability to provide guidance and oversight to junior staff.. Uphold quality standards by ensuring compliance with Pharmaceutical Quality Systems and with Global Standards and Process, providing support to ensure the efficacy of risk assessments, investigations, CAPAs and the robustness of technical discrepancy assessments.. Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt.. Have an agile mind set with ability to collaborate, improve and learn, have pride in ownership, focus on delivering value with the ability to adapt to change; and have the ability to make risk-based decisions.. Ability to question the status quo to drive continuous improvement.. Provide technical leadership to monitor process health through process monitoring, trouble shooting of processes and process equipment.. Provide technical leadership for the commissioning and validation of processes, process equipment and associated utilities by leading teams composed of cross functional SMEs.. Have the ability to identify process and equipment issues, analyze the potential risk, formulate and implement a corrective action.. Participate in system and equipment design, engineering documentation such as PFDs, P&IDs, URSs, Design Specifications, RFQs, contractor bid packages, equipment data sheets, piping isometrics, Installation/ Operation Qualification, Process Qualification and Process Validation.. Have the ability to author and/ or provide guidance for the authoring of controlled documents to support process validation, equipment commissioning, validation and maintenance of equipment and complex systems.. Interact with vendors concerning contracts of critical financial value and select vendors based on the most appropriate combination of price, quality and delivery. Review and approve vendor information packages, including drawings and specifications.. Supplementary Responsibilities:. Perform equipment and system studies, research/evaluate process equipment components, review/modify equipment operation as a result of troubleshooting.. Act as a team leader to coordinate activities and provide engineering leadership.. Present data and concepts at department, project team and other meetings within company and at outside conferences.. May provide direction to sub-contracting groups in the design and installation of process and clean utility systems. Oversee design specification testing and perform field inspection services.. May perform process design services for facility projects, upgrades and capacity expansions, equipment upgrading and replacement.. May propose ideas for new programs in alignment with strategic planning.. Qualifications / Requirements:. Bachelor's degree in Engineering (Chemical or Bio preferred) and 8 years' experience, or Master's degree in Engineering (Chemical or Bio preferred) and 6 years' experience.. Experience with cell culture process/ cGMP manufacturing is preferred.. Key to this position is the demonstrated ability to provide technical leadership and teamwork in a cGMP environment across functional and organizational boundaries. Excellent communication skills are a must. Ability to assess and develop timely, effective solutions for manufacturing equipment and processes is key. Six Sigma Green or Black Belts is a plus. Who We Are. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.. The next step is yours. To apply today, click on the \"Apply online\" button.. Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page .. Genentech, now a member of the Roche Group, is a leading biotechnology company that discovers, develops, manufactures and commercializes ...
Associated topics: bioengineering, biology, biomaterials, bioprocessing, biosynthetic, genetic, metabolic, molecular, neuro, pathogenesis

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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