Manufacturing Quality Engineer

2 weeks ago

austin, United States eTeam Full time

Job Title: Manufacturing Quality Engineer

Location: Austin, TX 78728

Duration: 11 Months

Shift: 3rd Shift 6:00 PM to 6:00 AM


Position Summary:

The Manufacturing Quality, Quality Engineer I (QE) is responsible for providing oversight and guidance in manufacturing operations ensuring manufacturing operations are operating under a state of GMP compliance. The QE will coach manufacturing personnel, on proper GMP and procedural compliance and empower them to identify and escalate quality issues, to ensure a quality product. The QEs are responsible for performing Safety Inspections on a scheduled frequency; they will identify and correct GMP issues while being expected to provide recommendations to management on corrective actions.


Essential Duties & Responsibilities:

Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure procedures are being followed in accordance with GMP compliance.

Conducts real time batch record reviews in assigned areas.

Reviews equipment logbooks and evaluates adjustments for impact to product quality.

Create, review, and revise procedures and assist with CAPA investigations as applicable.

Perform data analysis, identify corrective/preventive actions, and implement process improvements with a focus on quality processes.

Provide input and decision-making for quality in the manufacturing areas with regard to manufacturing events and deviations.

Provide corrective actions as necessary.

Monitors assigned area(s) for compliance to procedures and cGMPs specific to equipment, documentation, and personnel.

Performs quality review and approval of change control documentation related to preventive maintenance and calibration as assigned.

Conduct Safety Inspections and take prompt action to eliminate work hazards.

Initiate product and commodity restrictions in accordance with local procedures.

Perform other related duties as assigned or required.

Also, provide similar quality oversight functions for satellite locations as assigned or required.


Qualifications:

Bachelor’s degree in engineering or related field (STEM) from an accredited college or university is required

0-2 years of experience required

Previous pharma experience is preferred.

Experience in a clean room environment is desirable.

Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation, and initiative required.

Ability to work well with all levels of personnel throughout the facility.

Capable of rapidly absorbing technical data and the ability to apply this knowledge to a pharmaceutical manufacturing environment.


Travel Requirements:

Typically requires travel less than 5% of the time


Physical Requirements and Work Environment:

The MQ Quality Engineer role receives general direction daily from MQ supervisor and receives direction from MQ management as needed. The position requires both performance of duties in a manufacturing and office environment.

While working in the manufacturing environment:

Work is performed in a clean room environment. This requires the ability to adhere to the GMP requirements of the area.

There are high-noise areas, areas where radiological hazards or lasers may be encountered and/or areas where biological hazards may be encountered.

Must be able to occasionally move and lift objects of up to 40 lbs.

While working in the office:

This job operates in a professional office environment and routinely uses standard office equipment.

  • Manufacturing Quality Engineer

    3 weeks ago

    Austin, United States Astrix Technology Full time

    Manufacturing Quality Engineer Manufacturing Austin, TX, US Pay Rate Low: 23.00 | Pay Rate High: 25.00 + Added - 22/10/2024 Apply for Job _Our client, a global medical device company whose passion is to deliver high quality life-saving products, is looking for an Engieer I Manufacturing to join their team!_ **Engineer I Manufacturing - Overnight Shift** 1...

  • Manufacturing Quality Engineer

    1 week ago

    austin, United States eTeam Full time

    Job Title: Manufacturing Quality Engineer Location: Austin, TX 78728Duration: 11 MonthsShift: 3rd Shift 6:00 PM to 6:00 AMPosition Summary:The Manufacturing Quality, Quality Engineer I (QE) is responsible for providing oversight and guidance in manufacturing operations ensuring manufacturing operations are operating under a state of GMP compliance. The QE...

  • Manufacturing Quality Engineer

    2 weeks ago

    Austin, United States eTeam Full time

    Job Title: Manufacturing Quality Engineer Location: Austin, TX 78728Duration: 11 MonthsShift: 3rd Shift 6:00 PM to 6:00 AMPosition Summary:The Manufacturing Quality, Quality Engineer I (QE) is responsible for providing oversight and guidance in manufacturing operations ensuring manufacturing operations are operating under a state of GMP compliance. The QE...

  • Manufacturing Quality Engineer

    2 weeks ago

    Austin, United States eTeam Full time

    Job Title: Manufacturing Quality Engineer Location: Austin, TX 78728Duration: 11 MonthsShift: 3rd Shift 6:00 PM to 6:00 AMPosition Summary:The Manufacturing Quality, Quality Engineer I (QE) is responsible for providing oversight and guidance in manufacturing operations ensuring manufacturing operations are operating under a state of GMP compliance. The QE...

  • Quality Manufacturing Engineer

    3 days ago

    Austin, United States Manpower Engineering Full time

    Our client, a global leader in clinical healthcare products and technologies, is seeking a Manufacturing Quality Engineer to join their team. As a Quality Engineer, you will be responsible for providing oversight and guidance in manufacturing operations. Job Title: Manufacturing Quality Engineer Location: Austin, TX Pay Range: $32/hour - $38/hour What's the...

  • Quality Manufacturing Engineer

    3 weeks ago

    Austin, United States Manpower Engineering Full time

    Our client, a global leader in clinical healthcare products and technologies, is seeking a Manufacturing Quality Engineer to join their team. As a Quality Engineer, you will be responsible for providing oversight and guidance in manufacturing operations.Job Title: Manufacturing Quality EngineerLocation: Austin, TXPay Range: $32/hour - $38/hourWhat's the Job?...

  • Quality Manufacturing Engineer

    3 weeks ago

    Austin, United States Manpower Engineering Full time

    Our client, a global leader in clinical healthcare products and technologies, is seeking a Manufacturing Quality Engineer to join their team. As a Quality Engineer, you will be responsible for providing oversight and guidance in manufacturing operations.Job Title: Manufacturing Quality EngineerLocation: Austin, TXPay Range: $32/hour - $38/hourWhat's the Job?...

  • Quality Manufacturing Engineer

    1 week ago

    Austin, United States Manpower Engineering Full time

    Our client, a global leader in clinical healthcare products and technologies, is seeking a Manufacturing Quality Engineer to join their team. As a Quality Engineer, you will be responsible for providing oversight and guidance in manufacturing operations. Job Title: Manufacturing Quality EngineerLocation: Austin, TXPay Range: $32/hour - $38/hourWhat's the...

  • Manufacturing Quality Engineer

    1 week ago

    Austin, United States UCT Alumni Association Full time

    Join UCT and be part of the fastest-growing sector in the world! We indirectly touch every semiconductor chip that goes into every smartphone, smart car and device that uses artificial intelligence. This is a critical time for the semiconductor industry and for UCT - as technology evolves, we evolve with it. UCT is a diverse workplace where every talented...

  • Manufacturing Quality Engineer I

    1 month ago

    Austin, Texas, United States ICU Medical Full time

    Job SummaryThe Manufacturing Quality Engineer I is responsible for ensuring manufacturing operations are in compliance with Good Manufacturing Practices (GMPs). This includes coaching manufacturing personnel on proper procedures and empowering them to identify and escalate quality issues.Key ResponsibilitiesConduct evaluations and compliance walkthroughs of...

  • Manufacturing Quality Engineer I

    3 weeks ago

    Austin, United States ICU Medical Full time

    DescriptionPosition SummaryThe Manufacturing Quality, Quality Engineer I (QE) is responsible for providing oversight and guidance in manufacturing operations ensuring manufacturing operations are operating under a state of GMP compliance. The QE will coach manufacturing personnel, on proper GMP and procedural compliance and empower them to identify and...

  • Manufacturing Quality Engineer I

    1 month ago

    Austin, Texas, United States ICU Medical Full time

    Job SummaryThe Manufacturing Quality Engineer I is responsible for ensuring manufacturing operations are operating under a state of GMP compliance. This includes coaching manufacturing personnel on proper GMP and procedural compliance, empowering them to identify and escalate quality issues, and performing Safety Inspections on a scheduled frequency. The...

  • Manufacturing Quality Engineer I

    3 weeks ago

    Austin, United States ICU Medical Full time

    DescriptionPosition SummaryThe Manufacturing Quality, Quality Engineer I (QE) is responsible for providing oversight and guidance in manufacturing operations ensuring manufacturing operations are operating under a state of GMP compliance. The QE will coach manufacturing personnel, on proper GMP and procedural compliance and empower them to identify and...

  • Manufacturing Engineer

    1 month ago

    Austin, United States PSC Biotech Full time

    PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled...

  • Manufacturing Engineer

    1 month ago

    Austin, United States PSC Biotech Full time

    PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled...

  • Manufacturing Process Engineer

    4 weeks ago

    Austin, Texas, United States AVIAT US, Inc. Full time

    About the Role:The Manufacturing Engineering team at Aviat Networks collaborates with design engineering to introduce digital point-to-point microwave systems. This includes building prototypes, delivering products at scale, and transferring product and process knowledge to contract manufacturing partners.Responsibilities:Develops, validates, and implements...

  • Manufacturing Engineer

    3 weeks ago

    Austin, United States PSC Biotech Full time

    Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global...

  • Manufacturing Engineer

    3 weeks ago

    Austin, United States PSC Biotech Full time

    Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global...

  • Manufacturing Engineering Supervisor

    4 weeks ago

    Austin, Texas, United States Dover Fueling Solutions Full time

    Job Summary: We are seeking a highly skilled Manufacturing Engineering Supervisor to join our team at Dover Fueling Solutions. As a key member of our manufacturing operations, you will be responsible for developing and implementing manufacturing processes to ensure proper product functionality and cost efficiency. Key Responsibilities:Supervise and direct...

  • Supervisor, Manufacturing Engineering

    2 months ago

    Austin, United States Dover Fueling Solutions Full time

    Job Requisition ID: 57475Department: Manuf. & Operations (DEPT_MFGOP)At Dover Fueling Solutions (DFS), we are taking fueling and convenience retail to the next level. We are passionate about cultivating excellence in everything we do, but what really fuels us is our people. They’re the heart of our company. As an employee, our promise to you is that...