Senior Quality Engineer

3 weeks ago

Philadelphia, United States Katalyst Healthcares and Life Sciences Full time
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 and in remote facilities such as Philadelphia, PA and the Tampa Labs
  • Creating and maintaining company documentation, such as quality manuals, and quality procedures.
  • pplying good manufacturing practice and observing that it is being adhered to.
  • 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.
  • bility 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.
  • 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
  • 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.
Requirements:
  • 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.
  • 2+ years of experience in a Quality role is highly desirable.
  • Demonstrable experience creating and utilizing inspection/testing systems.
  • Experience with cell and/or gene therapy products
  • GMP regulated laboratory experience
  • Knowledge of investigation writing
  • This position will work in both an office and a manufacturing lab setting.
  • When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
  • ble to work in cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors.

  • Senior Quality Engineer

    2 weeks ago

    Philadelphia, United States Planet Pharma Full time

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

  • Senior Quality Engineer

    2 weeks ago

    Philadelphia, United States Planet Pharma Full time

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

  • Senior Quality Engineer

    3 days ago

    Philadelphia, United States Iovance Biotherapeutics Inc Full time

    Job DescriptionJob DescriptionSalary: Iovance is hosting an onsite Job Fair. Where: Iovance Cell Therapy Center (iCTC)  Location: 300 Rouse Blvd Philadelphia, PA 19112  Date: Monday, June 24, 2024 Time: 12pm to 6pm (EDT)   What to bring: Updated resumeWe are Hiring!  We look forward to seeing you at the Job Fair. OverviewThe Senior Quality...

  • Senior Quality Engineer

    7 days ago

    Philadelphia, United States Katalyst HealthCares & Life Sciences Full time

    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...

  • Sr Quality Engineer

    1 week ago

    Philadelphia, United States Planet Pharma Full time

    Sr Quality Engineer Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below. 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...

  • Sr Quality Engineer

    2 weeks ago

    Philadelphia, United States Planet Pharma Full time

    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 technically strong Overview The Senior Quality Engineer, Quality Assurance Engineering will...

  • Sr Quality Engineer

    2 weeks ago

    Philadelphia, United States Planet Pharma Full time

    Sr Quality EngineerNeeds 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 locationNeed to be positive, a team player, and someone technically strongOverviewThe Senior Quality Engineer, Quality Assurance Engineering will provide...

  • Sr Quality Engineer

    2 weeks ago

    Philadelphia, United States Planet Pharma Full time

    Sr Quality EngineerNeeds 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 locationNeed to be positive, a team player, and someone technically strongOverviewThe Senior Quality Engineer, Quality Assurance Engineering will provide...

  • Sr Quality Engineer

    2 weeks ago

    Philadelphia, United States Planet Pharma Full time

    Sr Quality EngineerNeeds 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 locationNeed to be positive, a team player, and someone technically strongOverviewThe Senior Quality Engineer, Quality Assurance Engineering will provide...

  • Senior Biztalk Engineer

    2 weeks ago

    Philadelphia, United States CapB InfoteK Full time

    For one of our ongoing multiyear project we are looking for a Senior Biztalk Engineer out of Philadelphia, PASkills: Senior Biztalk Engineer’s work in conjunction with developers of all skill levels, business analysts, and business owners · Contributes to technical design including high-level conceptual diagram, Biztalk development and mapping, service...

  • Quality Engineer

    3 days ago

    Philadelphia, United States Orion Talent Full time

    Description 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!), 401K with up to 6% Match, Paid Time Off (19 days for 0-3yrs...

  • Senior Bridge Engineer

    4 weeks ago

    Philadelphia, United States Pennoni Full time

    Job DescriptionPennoni is a multidisciplinary consulting engineering firm founded more than five decades ago. We approach engineering challenges from a wider spectrum of angles than most, from land development to energy management. Our goal is to help communities and private sector clients alike navigate the ever-changing technological advancements available...

  • Senior Traffic Engineer

    2 weeks ago

    Philadelphia, United States Whitman, Requardt & Associates, LLP Full time

    Job DescriptionJob DescriptionAt Whitman, Requardt & Associates, LLP, we are "People Focused and Project Driven". We have been in business for more than 105 years and we are known for our quality work and quality employees. This is your chance to join our team - help us to design the infrastructure and buildings that improve the world!We are currently...

  • Senior Project Engineer

    3 weeks ago

    Philadelphia, United States Altezas Full time

    Job Description: Altezas is seeking an experienced Project or Senior Project Engineer to join our team in Norristown, PA. As a Project or Senior Project Engineer, you will manage and deliver projects in the water, wastewater, gas, and telecommunications sectors. Responsibilities: Provide leadership, mentorship, and oversight working with a diverse team of...

  • Senior Project Engineer

    1 month ago

    Philadelphia, United States Altezas Full time

    Job Description:Altezas is seeking an experienced Project or Senior Project Engineer to join our team in Norristown, PA. As a Project or Senior Project Engineer, you will manage and deliver projects in the water, wastewater, gas, and telecommunications sectors. Responsibilities: • Provide leadership, mentorship, and oversight working with a diverse team of...

  • Senior Project Engineer

    2 weeks ago

    Philadelphia, United States Altezas Full time

    Job Description:Altezas is seeking an experienced Project or Senior Project Engineer to join our team in Norristown, PA. As a Project or Senior Project Engineer, you will manage and deliver projects in the water, wastewater, gas, and telecommunications sectors. Responsibilities: • Provide leadership, mentorship, and oversight working with a diverse team of...

  • Senior DeltaV Engineer

    2 weeks ago

    Philadelphia, United States Blackfield Associates Full time

    Blackfield Associates are currently supporting a large pharmaceutical manufacturer in Philadelphia with their search for a Senior DeltaV Engineer on a staff hire basis.This role provides the opportunity for a strong DeltaV Engineer to step into global automation projects and deliver $100mil+ new build projects as a team lead/SME. This is a key hire and we're...

  • Senior DeltaV Engineer

    2 weeks ago

    Philadelphia, United States Blackfield Associates Full time

    Blackfield Associates are currently supporting a large pharmaceutical manufacturer in Philadelphia with their search for a Senior DeltaV Engineer on a staff hire basis.This role provides the opportunity for a strong DeltaV Engineer to step into global automation projects and deliver $100mil+ new build projects as a team lead/SME. This is a key hire and we're...

  • Quality Engineer

    1 week ago

    Philadelphia, United States Leonardo Full time

    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 academy and stellar engineering team. We offer competitive compensation,...

  • Quality Engineer

    2 weeks ago

    Philadelphia, United States Leonardo Full time

    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 academy and stellar engineering team. We offer competitive compensation,...