Project Engineer
PharmaRegulatory AffairsQuality Assurancegmpemacroinformaws
Job description
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Role: Lead the technical definition, design and delivery of facility, utility and equipment projects within the site portfolio. Translate business needs, problem statements, user requirements and operational constraints into clear engineering concepts, scopes and technical solutions. Lead feasibility studies and option assessments, working with external partners, presenting recommendations, risks, assumptions and trade-offs to support decision-making. Develop or coordinate technical specifications, design requirements, tender packages and scopes of work. Review and challenge designs, calculations, drawings, specifications and other deliverables from engineering partners, vendors, suppliers and contractors. Ensure compatibility with existing systems and compliance with applicable engineering standards, cGMP requirements, EHS expectations, site procedures and regulatory requirements. Own or provide technical input to engineering assessments, Change Controls, risk assessments, deviations, CAPA actions and other quality records connected to assigned projects. Communicate technical status, decisions, priorities, risks and escalations clearly to Project Managers and relevant site stakeholders. Actively monitor contractor execution and acceptance of technical deliverables. Lead technical troubleshooting and root cause analysis when project or system issues require engineering support. Support or own the management of engineering documentation and drawings to ensure they remain current, controlled and traceable throughout the project and system lifecycle. Contribute to site engineering standards, templates, lessons learned and knowledge sharing across the Kite Network. Profile: Minimum of a bachelor’s degree in Engineering, Technology or a related technical discipline. At least 6 years of relevant engineering experience in a cGMP commercial manufacturing environment or another highly regulated industry. Demonstrated experience leading the technical design and engineering delivery of facility, utility or equipment projects. Ability to understand complex technical issues and translate operational or business needs into practical engineering solutions. Experience preparing or reviewing engineering specifications, feasibility studies, design packages, tender documentation and vendor deliverables. Knowledge of cGMP manufacturing, engineering change management, risk management, deviations, CAPA and regulatory requirements. Knowledge of equipment and system lifecycle activities, including qualification, handover and operational readiness. Strong troubleshooting, structured problem-solving, decision-making and technical communication skills. Ability to influence across functions, challenge constructively, manage competing priorities and communicate technical risks clearly. Self-starter and strong team player with excellent verbal, written and interpersonal communication skills. Strong attention to detail and good organizational skills. Preferred: experience of Engineering design software – AutoCAD, Revit Working with external design partners Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma . Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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