TucsonAZRecruiter Since 2001
the smart solution for Tucson jobs

Manager Senior Validations Engineering

Company: F. Hoffmann-La Roche AG
Location: Tucson
Posted on: April 8, 2021

Job Description:

SummaryAs the Senior Manager of Validations, you will lead a team that is responsible for the safe, reliable and cost effective validation of Process Control Systems, Plant Utility Systems, Environmentally Controlled Manufacturing areas and complex manufacturing, test and inspection equipment. You will continuously improve and expand capabilities in Validation Methods, Planning, Review and Documentation and advise the team on the selection and deployment of appropriate tools and standards. You will create and foster and environment of strong team spirit which includes timely and effective communications and a sense of urgency. You will be an active and visible leader that implements new and flexible solutions while ensuring the requirements of a complex manufacturing environment are met.Responsibilities

  • Develop, own and execute a site wide Validation plan (Including IQ/OQ/PQ) and continuously monitor, analyze, optimize and ensure the proper validation of facility systems, production equipment, inspection & test methodology, process control systems and production processes.
    • Provides technical knowledge of Validation principles and their application to deliver accurate objective evidence that requirements for a specific intended process/test/system or inspection methodology can be continually fulfilled.
      • Apply Program Management tools to define and monitor project timelines, ensuring timely achievement of overall project goals and establishing priorities that are in line with the overall business needs. Ensure resource requirements are properly documented and accounted for in the appropriate resource management tools
        • Generates and analyzes requirements and alternative architectures; develops preferred architectures for validations, communicates and coordinates with marketing and cross-functional development teams, and assists with managing the balance between development cost, schedule, quality and performance.
          • Participates or leads teams in efforts relating to system validation; supports cross functional teams in requirements definition, system decomposition and requirements allocation and requirements traceability and compliance including verification plans and reports.
            • Ensures the maintenance and continuous development of soft skills, technical expertise and personal development required by team in order to support product/process development initiatives. Maintains extensive knowledge of state-of-the-art principles, theories, and practices around Validation.
              • Lead, mentor and coach the team and partner organizations in the adoption and execution of Validation activities.
                • Perform other miscellaneous duties and special projects as assigned.QualificationsBachelor's Degree- BS in an Engineering/Engineering Technology or Life Science discipline required, PLUS10 years of experience with Complex mechanical/chemical systems development/validation 7 years of Leadership experience, preferably in regulated diagnostic/medical device environment5 Years of experience in a Regulated Industry preferably FDA and knowledge of Design Control Guidelines5 Years of Technical project management experience5 Years of demonstrated experience working in Requirements management toolsPrefer Master's Degree- MS in an Engineering/Engineering Technology or Life Science discipline ANDWith MS in Engineering: 6 or more years of experience in Complex mechanical/chemical systems development/validation ORWith PhD in Engineering: 4 or more years of combined academic and industry experience in Complex mechanical/chemical systems development/validation Knowledge, Skills and AbilitiesKnowledge of Verification and Validation principles practices and tools.Skill in applying state of the art, tools and practices, expertise and methodologies in the validation of complex systems to meet regulatory and compliance guidelines.Proven ability to work on complex problems with analysis of situations or data towards successful outcomes.Proven ability to lead and manage complex projectsSkill in identifying and hiring functional resources with appropriate skill set to support business needsProven ability to independently build, mentor, and lead teams to achieve development targets.Strong influencing skills to consistently achieve targeted results by levering your expertise, knowledge, interpersonal skills and organizational savvy.Demonstrated ability to apply Lean and 6 Sigma methodology in all that you do and a passion to drive It throughout the organizationProven ability to contribute and interact productively and collaboratively with project teams as a creative, innovative manager.Ability to exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining results.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com . We believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche. Suggested Jobs

Keywords: F. Hoffmann-La Roche AG, Tucson , Manager Senior Validations Engineering, Engineering , Tucson, Arizona

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Engineering Jobs


Electronics Engineer
Description: About br br The most secretive of Navy vessels, a submarine requires a select community of specially trained professionals to operate its classified, highly advanced hardware. The Sailors in the Submarine (more...)
Company: US Navy
Location: Tucson
Posted on: 04/19/2021

Remote Cloud Platform Quality Assurance Engineer
Description: A blockchain technology company is seeking a Remote Cloud Platform Quality Assurance
Company: VirtualVocations
Location: Tempe
Posted on: 04/19/2021

Telecommute Implementation Engineer
Description: A provider of universal communications APIs is filling a position for a Telecommute Implementation
Company: VirtualVocations
Location: Chandler
Posted on: 04/19/2021


Copper Springs Behavioral Health Technician - PRN
Description: Academic/Faculty/Research opening in Gilbert, Arizona. This and other rn jobs brought to you by NursingJobCafe.com Overview br br Copper Springs East is a 72-bed behavioral hospital located near Gilbert, (more...)
Company: Springstone, Inc
Location: Gilbert
Posted on: 04/19/2021

Data Analytics Engineer
Description: At Keap, we help small businesses succeed - and small businesses need timely and accurate data. That's why we're looking for a talented Data Engineer to work with us on solving interesting problems, in (more...)
Company: Infusionsoft
Location: Chandler
Posted on: 04/19/2021

Salesforce Engineer (FFAM)
Description: THE OPPORTUNITY: br In this role, as a Salesforce Engineer you will do day to day development activities, and primarily focus on custom development tasks on the Salesforce.com platform using Apex and (more...)
Company: Freedom Financial
Location: Tempe
Posted on: 04/19/2021

Quality Assurance Engineer II
Description: This is a multi-level position that can be a Quality Assurance Engineer II or Senior Quality Assurance Engineer I based on the candidates qualification as they relate to the skills, experience, and education (more...)
Company: RTX
Location: Sahuarita
Posted on: 04/19/2021

HVAC Technician Engineer - Marriott Hotels -21020517
Description: Live Fully at Marriott International 1 Leader in Hospitality At Marriott International, you have the opportunity to grow in your career, work with teammates that feel like family, and help make our world (more...)
Company: Marriott International, Inc.
Location: Sahuarita
Posted on: 04/19/2021

Mid-Level Signal Processing Engineer II - RF/EO/IR Algorithms, Models and Analysis (SPC)
Description: Are you a mid-career professional who wants to develop Signal Processing solutions to solve complex problems for Radar and/or Electro-Optical/Infrared EO/IR missile applications Do you have a passion (more...)
Company: RTX
Location: Tucson
Posted on: 04/19/2021

Pulse Power Engineer (Multi-Level)
Description: The Raytheon Missiles and Defense, Electrical Product Team is looking for Electrical Engineers responsible for developing, integrating, and demonstrating research based and proof of concept designs.We (more...)
Company: Raytheon Technologies
Location: Tucson
Posted on: 04/19/2021

Log In or Create An Account

Get the latest Arizona jobs by following @recnetAZ on Twitter!

Tucson RSS job feeds