Jobs
>
Braymer

    Continuous Improvement Senior Process Engineer - Swiftwater, United States - Taleo BE

    Taleo BE
    Taleo BE Swiftwater, United States

    3 weeks ago

    Default job background
    Description
    Manage Sr. Engineer Continuous Improvement - Swiftwater, PA

    The role of the Manager Sr.

    Process Engineer involves identifying, gaining consensus, and resolving safety, compliance, and efficiency issues that impact the Automated Visual Inspection in FFIP.

    This position actively contributes as a member of cross-functional teams, serving as an interface between the FFIP platform and the Technical Community.

    The Sr. Process Engineer is responsible for all activities related to the Continuous Improvement of Automated Visual Inspection for Drug Products.

    As an individual contributor within the organization, the role encompasses membership in cross-functional teams supporting FFaST (Focus Factory and Support Team) efforts, providing continuous improvement for the Factory with a focus on Automated Visual Inspection.

    Additionally, the Sr.

    Process Engineer provides project support for cross-functional teams, serving as the factory interface for addressing visual inspection and project-related issues.


    Key Accountabilities:


    Provides technical support/details for automated visual inspection to Engineering, Maintenance, Quality Assurance (QA), Quality Validation (QV) and Manufacturing Technology (M-Tech).

    Proficient on Automated Visual Inspection recipe creation, tuning and troubleshooting for vials and syringes within the FFIP platform.


    Responsible to train/mentor new and existing engineers on the visual inspection program that include recipe creation and tuning, troubleshooting and recipe management.

    Provide daily support to shopfloor managers on visual inspection operations.


    The ability to work independently or with other group to identify inspection issues, formulate solutions and implement changes as required.

    Utilizing the "+QDCI" Visual Management Systems and working with the FFIP Management Committee to drive improvements in key metrics.

    Ensure compliance with all regulatory requirements and good documentation are followed to provide a safe, quality, and effective product.

    This position will support both the needs of production as well as project related activities.


    The position will also require evaluation of automated visual inspection performance and finding ways to improve OEE and reduce false reject rate.

    Having a strong working knowledge of the relationship between automated visual inspection tools, parameters, product characteristics and critical quality attributes

    Coordinate project validation approach with P-tech, Engineering and Site Quality Operations.


    Strong customer communication and the ability to work with multiple groups to complete projects for new and existing equipment within the Inspection department.

    Responsible for the efficiency, and reliable operation of all automation visual inspection equipment.


    This position will have interactions with Health, Safety and Environment (HSE), Engineering, Site Quality Operations, Information Technology & Solutions, Outside Contractors/Consultants, Vendors, Industrial Operations and Research & Development departments.


    Providing technical coaching, training and guidance to inspection managers, maintenance personnel and junior engineers on visual inspection related subject matter.

    Leading tactical responses to equipment related deviations, Agency observations, delivering technical solutions and communicating outcomes to site management.

    Review/approve process design specifications, technical documents, validation project plans and assist on the execution of equipment validation.

    Author / review / execute/ approve technical documents which support equipment recipe tuning.

    Author Change Control which supports equipment, products related changes and project works.

    Promote innovation to keep up to date with the latest regulatory expectations and industry standards.


    Basic Qualifications:
    B.S. in electrical, mechanical and/or other applicable engineering field required.

    1-3 years in pharmaceutical or biotech manufacturing, maintenance, and engineering experience.

    Functional experience with machine vision and industrial machinery control.

    An understanding of current pharmacopeia guidance and regulations regarding visual inspection is desired.

    Requires 100% on-site present during normal workdays.

    Willing to provide support during the off-shit hours occasionally that include remote or on-site.

    Minimum of 2-years experiences working with automated equipment in a pharmaceutical cGMP or food industry environment or equivalent.

    Experience in the areas of customer support, operational excellence, and troubleshooting.


    Must have good written and verbal communication skills, as well as the ability to actively, and cooperatively work with cross functional teams.

    Manager Sr.

    Process Engineer FFast Continuous Improvement position is needed to support daily inspection operation activities and projects execution to alleviate equipment issues, process downtime, and improve the overall operation efficiency.

    This position will support the FFIP platform and functions as the Visual Inspection Engineer to interface between the Visual Inspection Operations and the Technical Community.

    Additionally, this position will provide technical coaching, training and guidance to inspection managers, maintenance personnel and junior engineers on visual inspection related issues.

    Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.

    All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.


    Learn more about Sanofi M&S:
    #GD-SP
    #LI-SP

    Pursue

    progress , discover

    extraordinary

    Better is out there. Better medications, better outcomes, better science.

    But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing:
    a desire to make miracles happen. So, let's be those people.


    At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

    Watch our

    ALL IN video

    and check out our Diversity Equity and Inclusion actions at

    #J-18808-Ljbffr


  • Sanofi EU Swiftwater, United States

    Job Title: Continuous Improvement Senior Process Engineer · Swiftwater, PA About the Job · We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and a ...


  • Sanofi EU Swiftwater, United States

    Job Title: Continuous Improvement Senior Process Engineer · Swiftwater, PA · About the Job · We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent a ...


  • Sanofi EU Swiftwater, United States

    Job Title: Continuous Improvement Senior Process Engineer · Swiftwater, PA · About the Job · We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and a ...

  • PSG Global Solutions Careers

    Process Engineer V

    2 weeks ago


    PSG Global Solutions Careers Swiftwater, United States

    Apply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Process Engineer V, working in Pharmaceuticals and Medical Products industry in 1 Discovery Drive, Swiftwater, Pennsylvania, 18370, Un ...

  • PSG Global Solutions Careers

    Process Engineer V

    1 week ago


    PSG Global Solutions Careers Swiftwater, United States

    Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Process Engineer V, working in Pharmaceuticals and Medical Products industry in 1 Discovery Drive, Swiftwater, Pennsylvania, 18370, United Stat ...


  • The Fountain Group Swiftwater, United States

    Job Description: Support manufacturing toward industrial excellence to guarantee the accuracy, conformity, and competitiveness of the processes and techniques utilized to produce the vaccines and biologics manufactured onsite. · Write protocols, reports, procedures, and memos as ...


  • Pyramid Consulting Swiftwater, United States

    Immediate need for a talented · Validation Specialist III (Engineering). · This is a · 12+ months Contract · opportunity with long-term potential and is located in · Swiftwater, PA(Onsite). · Please review the job description below and contact me ASAP if you are interested. ...


  • Pyramid Consulting Swiftwater, United States

    Immediate need for a talented Validation Specialist III (Engineering). This is a 12+ months Contract opportunity with long-term potential and is located in Swiftwater, PA(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay ...


  • Oxford and Associates Swiftwater, United States

    Summary: · Perform tactical work and review a variety of documents, protocols, and reports. · Project Details: · Exhibit varying levels of experience and a solid progression of work and/or trainingDocument, review and batch disposition of API and drug product used in Phase 1-3 ...

  • SSi People

    Validation Engineer

    3 weeks ago


    SSi People Swiftwater, United States

    Experience in cleaning validation in the biologics or vaccine industry to include the following: · o Experience in authoring, reviewing, executing and approving validation documents. · o Interface with Quality organization and the ability to defend rationale in validation documen ...


  • Aequor Swiftwater, United States

    Validation Specialist III · Location: Swiftwater, PA (Hybrid) · Duration: Contract till March 2025 with possibility to extend · Only W2 · THIS IS A CLEANING VALIDATION POSITION. · Mostly hybrid - will usually be 4 days onsite and one remote but manager prefers flexibility just in ...


  • cyberThink Inc Swiftwater, United States

    Job Description: · This position of Validation Specialist is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at ...


  • The Fountain Group Swiftwater, United States

    Job Description: · Support manufacturing toward industrial excellence to guarantee the accuracy, conformity, and competitiveness of the processes and techniques utilized to produce the vaccines and biologics manufactured onsite. · Write protocols, reports, procedures, and memos a ...


  • PSG Global Solutions Careers Swiftwater, United States

    Apply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Project Engineer Design Lead, working in Pharmaceuticals and Medical Products industry in 1 Discovery Drive, Swiftwater, Pennsylvania, ...


  • cyberThink Swiftwater, United States

    Job Description: · This position of Validation Specialist is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at ...


  • cyberThink Swiftwater, United States

    Job Description: · This position of Validation Specialist is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at t ...


  • Sanofi Group Swiftwater, United States

    Who We Are · At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for m ...


  • Pyramid Consulting Swiftwater, United States

    Immediate need for a talented Validation Specialist III (Engineering). This is a 12+ months Contract opportunity with long-term potential and is located in Swiftwater, PA(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: (phone ...


  • Artech Swiftwater, United States

    THIS IS A CLEANING VALIDATION POSITION. · Duties · ________________________________________ · " Experience in cleaning validation in the biologics or vaccine industry to include the following: · o Experience in authoring, reviewing, executing and approving validation documents. · ...


  • Oxford and Associates Swiftwater, United States

    Summary: · Perform tactical work and review a variety of documents, protocols, and reports. · Project Details: · Exhibit varying levels of experience and a solid progression of work and/or training · Document, review and batch disposition of API and drug product used in Phase 1-3 ...