Principal Engineer, Global Technical Operations, Engineering & Innovation

LEON PCI Pharma Services Bedford, NH, USA Leon, Spain Full time JR Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Principal Engineer, Integral Technical Operations, Engineering, & Innovation The Principal Engineer (Global Technical Operations, Engineering & Innovation), acting as a subject matter expert, provides oversight in the design of state of the art isolated sterile fill finish and lyophilization equipment and supporting plant systems through direct involvement and/or managing a cross functional team, supports fine tuning and continuous improvement objectives in assuring equipment or systems operate at optimal performance. The Global Principal Engineer is responsible for providing technical leadership and management in the delivery of Front End Engineering Designs which includes cross functional collaboration to develop Project Charters, Project Scope Definitions, Project Business Requirements (business case), and economic evaluations needed to support project approvals, stage gate reviews, project governance, etc. This position requires ability to interact and galvanize input through all levels of the organization including Senior Leadership and C Suite. Responsible for driving segment level standardization of engineering and facilities approaches, tools, ways of working, Lean Manufacturing, and Continuous Improvement. Supports master planning, manufacturing asset assessments, and 5 year CapEx planning across the segment in alignment with enterprise priorities. Provides engineering mentoring to Site engineering teams in collaboration with engineering management. Essential Duties and Responsibilities

Be Subject Matter Expert (SME) in isolated or RABS sterile fill finishing and lyophilization equipment and operations. Manages Front End Engineering Design efforts to develop project scopes, cost estimates, and schedules in accordance with identified project priorities and business objectives providing deliverables for the foundation of business case evaluations in a CDMO environment. Manages external engineering partners and internal cross functional teams in the execution and delivery of Front End Engineering Designs Develop and implement segment level engineering standards, establishing clear baseline requirements and governance to drive consistency across engineering and facilities teams. Drive standard work creation and process documentation discipline. Investigate, develop, and recommend alternatives for design, procurement, and installation of new/modified equipment or systems for the optimal utilization and control of resources. Institute project teams and governance structures. Lead and execute site Manufacturing Asset Assessments across the segment. Lead and execute Site Master Planning across the segment. Conduct troubleshooting and/or technical analyses on operational equipment and processes. Establish Project Charters including scope of work, goals, and deliverables in collaboration with project champion/sponsor to support business objectives in alignment with senior leadership and key stakeholders. Organize project governance requirements and subsequently coordinating communications and meetings in compliance with the governance. Liaise with project stakeholders on an ongoing basis. Ensures inclusion of Global Quality Tech Operations personnel in key decisions and project delivery efforts. Ensures inclusion of Site Operations (Manufacturing, Engineering, Quality, Validation, etc) personnel in site related projects and continuous improvement efforts. Drive a culture of Lean Manufacturing and Continuous Improvement at all levels within the organization through the use the site maturity index. Developing metrics to manage, evaluate, and communicate progress on assigned tasks, projects, improvement efforts, etc. Leads the implementation of major capital projects as needed. Provide technical support through the gate process, during pre-construction phase, and coordinate daily activities with the production area and project management and contractors. Prepare URS, Risk Assessments, Safety Assessments associated with the project. Leads the effort with end users to develop system requirements, specification of equipment/buildings, review design from outside engineering firms or contractors (as needed), overseeing fabrication and leading Factory/Site Acceptance Testing. Demonstrate the ability to engage, motivate and positively influence others in the pursuit of achieving PCI goals.



Supports safety through personal engagement and promote individual accountability for safety across the operational segment. Ensure risks to employee health and safety are rigidly controlled in compliance with the PCI PHARMA SERVICES Environmental Health and Safety procedures. Act as a champion and change agent in support of the Global Engineering team and other continuous improvement efforts. Effectively support internal and external relationships, key stakeholders, vendors. Strong communication skills Qualifications

Required

BS in Chemical, Mechanical, or other Engineering degree from an accredited university is required. Project Management Professional (PMP) certification or similar accreditation is required. Masters degree in Engineering preferred Preferred

A minimum of 15 years experience in cGMP related engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device, or pharmaceutical industry. A minimum of 10 years experience in a life science contract, development, and manufacturing Organization (CDMO) environment. A minimum of 5 years people supervision and management experience. A minimum of 5 years experience working in procurement environment exhibiting negotiation skills and bidding/proposal evaluation leading to decisions on vendor selection. A minimum of 5 years experience with continuous improvement and hands on innovation ideation platforms. Must have experience in aseptic processing. Experience with aseptic liquid filling of vials, cartridges, and syringes under isolated and RABS environments; aseptic lyophilization; and aseptic processes, including refrigerated and frozen capabilities. #LI-CW1 Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. El equipo de ingeniería de mantenimiento y fiabilidad (RME) de Amazon es fundamental para nuestras operaciones, ya que se encarga de mantener la maquinaria esencial en funcionamiento de forma permanente. Como técnico/a de mantenimiento, te encargarás de revisar una gran variedad de maquinaria y espacios de trabajo, velando siempre por las buenas prácticas en materia de salud y seguridad. Ayudarás a proteger a los miembros de tu equipo y a prevenir las interrupciones de la actividad. Nuestros/as técnicos/as de mantenimiento y fiabilidad multiplican la disponibilidad y calidad de nuestra maquinaria, además de procurar la mejora del entorno operativo. Key job responsibilities

Llevar a cabo tareas de mantenimiento proactivo y de prevención de una gran variedad de equipos. Realizar reparaciones reactivas y diagnósticos de averías en un almacén de distribución en funcionamiento.



Utilizar las herramientas más modernas para maximizar la eficacia de los equipos. Respetar todas las políticas y prácticas en materia de salud y seguridad. Contribuir al desarrollo y la formación de los empleados en prácticas. Trabajar en proyectos de mejora continua e implantar buenas prácticas en distintos centros de la UE. A day in the life

Nuestros/as técnicos/as de mantenimiento y fiabilidad trabajan sobre el terreno en nuestros centros, lo que les permite responder rápidamente ante cualquier problema que surja con la maquinaria. Te encargarás del mantenimiento preventivo planificado de los equipos de nuestras instalaciones para garantizar que funcionen con seguridad. Como técnico/a de ingeniería de mantenimiento y fiabilidad, también deberás reaccionar con celeridad ante cualquier avería, investigando, identificando y aplicando soluciones lo antes posible. También propondrás mejoras a largo plazo. Te encargarás de las tareas diarias de mantenimiento, como pintura y fontanería, codo con codo con los miembros sénior de tu equipo, y te pondrás en contacto con contratistas si hace falta ayuda externa. Trabajarás en distintos turnos para garantizar que nuestros centros cuentan con un servicio de asistencia las 24 horas del día, lo que permitirá a Amazon realizar sus entregas a la velocidad acostumbrada. About the team

Nuestro equipo de ingenieros de mantenimiento y fiabilidad (RME) se encarga de que nuestros sistemas funcionen a pleno rendimiento. Nos caracterizamos por nuestra gran aptitud técnica y nuestra excelente capacidad para el trabajo en equipo, liderados por unos responsables con gran experiencia. Nuestro trabajo comprende el mantenimiento, la reparación y la solución de problemas relacionados con los equipos en toda nuestra red mundial de centros de distribución. El equipo cuenta con una serie de perfiles de dirección que se encargan de supervisar el desarrollo de tecnologías fascinantes, algunas de las cuales solo existen en Amazon. Nuestro equipo se ocupa de la mayoría de los aspectos técnicos de Amazon, desempeñando tareas que van desde la instalación de sistemas automatizados de embalaje hasta la supervisión del mantenimiento general de un centro o la reparación de equipos clave de distribución. Esto incluye adaptar los edificios a la legislación vigente, para que todo el personal esté seguro y nuestras instalaciones funcionen con la mayor eficiencia posible. El equipo de RME, al igual que ocurre en otros departamentos de Amazon, ofrece numerosas oportunidades de progresar profesionalmente. Todo nuestro trabajo gira en torno a reducir los periodos de inactividad en los centros de operaciones cruciales de Amazon, para que los clientes reciban sus pedidos a tiempo. Con frecuencia, trabajamos de madrugada o a altas horas de la noche para poder realizar las tareas de mantenimiento ocasionando las mínimas molestias, por lo que hacemos turnos nocturnos. Si descubrimos que hay una forma mejor de hacer algo, tenemos la capacidad y la posibilidad de desarrollar e introducir procesos totalmente nuevos o tecnología punta, como Amazon Robotics y nuestro clasificador de artículos complejos. BASIC QUALIFICATIONS

Experiencia en sistemas de mantenimiento preventivo programado Experiencia en tareas de mantenimiento mecánico y/o eléctrico. Experiencia en búsqueda de fallos de sistemas MHE (del inglés: Material Handling Equipment) /Automatización. Nivel avanzado de español, tanto oral como escrito. PREFERRED QUALIFICATIONS

Los requisitos deseables son un plus, pero no son obligatorios para solicitar el puesto. Si cumples los requisitos básicos mencionados, nos encantaría conocerte. Experiencia en la monitorización basada en el estado. Experiencia en el manejo de máquinas de impresión y aplicación de etiquetas. Experiencia en la detección de averías y el mantenimiento de sistemas de transporte o automatización. Amazon is an equal opportunities employer. We believe passionately that employing a diverse workforce is central to our success. We make recruiting decisions based on your experience and skills. We value your passion to discover, invent, simplify and build. Protecting your privacy and the security of your data is a longstanding top priority for Amazon. Please consult our Privacy Notice ( ) to know more about how we collect, use and transfer the personal data of our candidates. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.

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