Jobs
>
Philadelphia

    Senior Quality Engineer - Philadelphia, United States - Planet Pharma

    Planet Pharma
    Planet Pharma Philadelphia, United States

    2 weeks ago

    Default job background
    Description

    (This is a full time permanent position available for people located in the Philadelphia, PA area)

    Overview

    The Senior Quality Engineer, Quality Assurance Engineering will provide Quality oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility along with associated software applications. This Senior Quality Engineer, Quality Assurance Engineering will be responsible for supporting the design, installation and evaluation of equipment, utilities, components, products and computer systems while ensuring they are fully operational, effective and free from defects during the entire system lifecycle. Further support the formulation of quality policies, procedures as well as conducting training on quality concepts/tools. In addition, the Senior Quality Engineer will support audit and submission activities for regulatory compliance.

    Essential Functions and Responsibilities

    • Identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups such as Manufacturing, Quality Control, IT, Engineering and Validation.
    • Supporting the oversight of Data Integrity and Computer System Validation efforts, system lifecycle and improvements.
    • Supporting cGMP quality improvement efforts at iCTC (Philadelphia, PA) and in remote facilities such as IOVA-A (Philadelphia, PA) and the Tampa Labs (Tampa Bay, FL).
    • Creating and maintaining company documentation, such as quality manuals, and quality procedures.
    • Applying good manufacturing practice and observing that it is being adhered to.
    • Represent Quality on cross-functional teams to complete projects, address quality issues and implement quality system improvements.
    • Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes and disposition of discrepant material.

    Required Education, Skills, and Knowledge

    • BA/BS degree in scientific or engineering discipline
    • 5+ years of biopharmaceutical industry experience in a technical or supporting technical role
    • 3+ years leading or supporting GxP Computer System implementation and validation
    • Demonstrable experience creating and utilizing inspection/testing systems.
    • Strong experience developing and executing protocols for single-use process systems, lab systems and software applications in a cGMP environment
    • Demonstrable experience creating and maintaining policies, processes and procedures for a new cGMP facility
    • Demonstrable experience utilizing risk-based assessments and setting up lifecycle verification programs for manufacturing and laboratory systems.
    • Ability to effectively communicate with management and project team members
    • Experience in preparing for and participating in regulatory inspections to ensure successful outcomes
    • Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
    • Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders
    • Ability to meet deadlines and multi-task efficiently
    • Must be comfortable in a fast-paced environment with minimal direction and changing priorities
    • Experience identifying changes, driving improvements, and streamlining processes required
    • Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project

    Preferred Education, Skills, and Knowledge

    • 2+ years of experience in a Quality role

    Physical Demands and Activities Required:

    • Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
    • Must meet requirements for and be able to wear a half-face respirator.
    • Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
    • Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
    • Must be able to lift and carry objects weighing 45 pounds.

    *The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

    Pay Range: $70-110k *Salary dependent on experience

  • Phoenix Innovations

    Quality Engineer

    3 weeks ago

    Phoenix Innovations Drexel, United States

    Feintool stands for extreme attention to detail. Our precision in cutting, pressing, stamping, and forming metal parts, especially for transmissions, has made us great. · We have been around since 1959, with 3,500 employees at 19 locations in Europe, North America, and Asia. We a ...

  • Leonardo

    Quality Engineer

    3 weeks ago

    Leonardo Philadelphia, United States

    Leonardo Helicopters is a multinational company, producing helicopters deployed in more than 150 countries across the globe. Leonardo Helicopters U.S. headquarters has been in Philadelphia since 1980 and is home to a world-class production facility, maintenance center, training a ...

  • Leonardo

    Quality Engineer

    1 week ago

    Leonardo Philadelphia, United States

    Leonardo Helicopters is a multinational company, producing helicopters deployed in more than 150 countries across the globe. Leonardo Helicopters' U.S. headquarters has been in Philadelphia since 1980 and is home to a world-class production facility, maintenance center, training ...

  • Orion Talent

    Quality Engineer

    2 weeks ago

    Orion Talent Philadelphia, United States

    · Title: Quality Engineer · Location: Philadelphia, PA · Shifts: M-F Days · Compensation: $85k-$95k base salary, plus annual bonus and merit increases based on performance · Benefits: Comprehensive benefit package includes a fully paid medical, dental and vision plan (no mon ...

  • Leonardo

    Quality Engineer

    2 weeks ago

    Leonardo Philadelphia, United States

    Leonardo Helicopters is a multinational company, producing helicopters deployed in more than 150 countries across the globe. Leonardo Helicopters' U.S. headquarters has been in Philadelphia since 1980 and is home to a world-class production facility, maintenance center, training ...

  • Orion Talent

    Quality Engineer

    3 weeks ago

    Orion Talent Philadelphia, United States

    Title: Quality Engineer Location: Philadelphia, PA Shifts: M-F DaysCompensation: $85k-$95k base salary, plus annual bonus and merit increases based on performanceBenefits: Comprehensive benefit package includes a fully paid medical, dental and vision plan (no monthly premium), 40 ...

  • AgustaWestland Philadelphia Corporation

    Quality Engineer

    3 days ago

    AgustaWestland Philadelphia Corporation Philadelphia, United States

    Job Title: Quality Engineer · Department: Quality Assurance · Reports to: Manager, Quality Assurance · Direct Reports: No · Location(s): Philadelphia · Summary of Position: · Represents Quality Assurance function to integrate Quality Management System requirements; provides Qu ...

  • FreedomPay

    Quality Engineer

    2 weeks ago

    FreedomPay Philadelphia, United States

    Job ResponsibilitiesEnsure the delivery of high quality and rigorously consistent productsContribute to the design of the company's quality standards and processesDiscover, identify, and document defectsSolutions for managing system riskContribute to quality process improvementIn ...

  • PEI Genesis

    Quality Engineer

    3 weeks ago

    PEI Genesis Philadelphia, United States

    Job DetailsLevelExperiencedJob LocationPEI-Genesis Philadelphia HQ - Philadelphia, PAPosition TypeFull TimeEducation Level4 Year DegreeJob CategoryQA - Quality ControlDescription*COVID-19 VACCINATION REQUIRED FOR EMPLOYMENT**Equal Opportunity Employer Veterans/Disabled*SUMMARY:Su ...

  • PCi Corporation

    Quality Engineer

    3 days ago

    PCi Corporation Philadelphia, United States

    Red Lion Road-PA002 · Position Title: Quality Engineer · Location: Philadelphia, PA - Red Lion Road · Department: Quality -- Validations · Shift: 1st · Reporting To: Director of Validation · Responsible For (Staff): no · The Quality Engineer has the primary function of supporting ...

  • PEI Genesis

    Quality Engineer

    2 weeks ago

    PEI Genesis Philadelphia, United States

    Job Details · Level · Experienced · Job Location · PEI-Genesis Philadelphia HQ - Philadelphia, PA · Position Type · Full Time · Education Level · 4 Year Degree · Job Category · QA - Quality Control · Description · *COVID-19 VACCINATION REQUIRED FOR EMPLOYMENT* · *Equal ...

  • Veradigm

    Quality Engineer

    3 weeks ago

    Veradigm Philadelphia, United States

    Welcome to Veradigm Our Mission is to be the most trusted provider of innovative solutions that empower all stakeholders across the healthcare continuum to deliver world-class outcomes. Our Vision is a Connected Community of Health that spans continents and borders. With the larg ...

  • Apex Innovations

    Quality Engineer

    2 days ago

    Apex Innovations Chester, United States

    AUMA - an innovative, medium-sized family business headquartered in Müllheim i. M. - has been developing, producing and distributing electric actuators and valve gearboxes for various industries such as water and energy for 60 years. With 2,800 employees worldwide, AUMA is one of ...

  • Aerojet Rocketdyne

    Quality Engineer

    3 days ago

    Aerojet Rocketdyne East Camden, United States

    Job Title: Senior Specialist, Quality Engineer · Job Code: 9449 · Job Location: Camden, AR · Job Schedule: 4/10 – 10 hours Monday – Thursday · Job Description: · Aerojet Rocketdyne, an L3Harris Technologies Company, is seeking a Sr. Specilaist, Quality Engineer to join our growin ...

  • Armtec Defense Technologies

    Quality Engineer

    3 weeks ago

    Armtec Defense Technologies East Camden, United States

    Company Overview · Armtec Defense Technologies (Armtec) is an operating unit of the Transdigm Group (NYSE: TDG), an industry leader in aerospace and defense products and services. Armtec is comprised of three business units producing subcomponents for ordnance in Coachella, CA; d ...

  • Lockheed Martin

    Quality Engineer

    3 weeks ago

    Lockheed Martin Camden, United States

    · Description:Lockheed Martin is seeking to hire an Quality Engineering professional to support our Missiles and Fire Control campus in Camden, Arkansas. · Our operations utilize state of the processes to produce and validate hardware for sophisticated missile systems and assoc ...

  • Team Trident LLC

    Quality Engineer

    2 weeks ago

    Team Trident LLC Camden, United States

    Job Description · Job DescriptionProvides Quality Engineering direction including (but not limited to) these areas: · Requirements flow-down: Ensure program design and process documents for area of responsibility include program quality requirements and that products are inspect- ...

  • Orion Talent

    Aerospace Quality Engineer

    2 weeks ago

    Orion Talent Philadelphia, United States

    The Quality Engineer represents the Quality Assurance function to integrate Quality Management System requirements. You will provide Quality interpretation of requirements, ensure adherence to company and regulatory requirements, and participate in various reviews to assure quali ...

  • Derbyshire Machine & Tool Company

    Quality Assurance Engineer

    1 week ago

    Derbyshire Machine & Tool Company Philadelphia, United States Full time

    Are you ready to take your career to the next level? Do you have a passion for ensuring precision and reliability in cutting-edge defense systems? We invite you to be a part of our dynamic team at Derbyshire Machine and Tool Company as a Quality Engineer · At Derbyshire Machine a ...

  • Planet Pharma

    Sr Quality Engineer

    2 weeks ago

    Planet Pharma Philadelphia, United States

    Sr Quality Engineer · Needs to be a strong QA Engineer who has experience with Quality Assurance related computer system implementation - needs to have worked in a cGMP/GMP/GxP environment. · Fully onsite in PA location · Need to be positive, a team player, and someone technical ...