Manufacturing Engineer Job Listing at Kelly Services in Pittsburgh, PA (Job ID US3621351_BH10020215)

Description

Equipment Engineer | Pittsburgh, PA

On-Site | Direct Hire

 

Perform activities associated with the equipment program related to equipment used within the AMDC manufacturing process and in support labs.

 

Responsibilities

• Maintains a solid understanding of the equipment used within the cGMP manufacturing process and utilizes that understanding within projects, risk assessments, decision making, audit support, and day-to-day operations.
• Assists in the development of equipment-based programs (in collaboration with the Metrology Department, process owners and Quality Assurance).
• Provides technical support for equipment associated with the cGMP manufacturing process, and provides feedback associated with internal and external queries relating to equipment used in the cGMP manufacturing process, including audits.
• Completes equipment related documentation for cGMP and non-cGMP equipment systems.
• Participates and leads investigations, CAPAs, and change controls pertaining to process equipment.
• Guides and trains engineers, process owners, and system owners on equipment related functions as required.
• Performs commissioning and decommissioning activities of equipment, including protocol development and execution.
• Creates and maintains all procedures associated with operation, maintenance, and calibration of equipment, including use of CMMS system.
• Implements CAPAs stemming from investigations or observed trends and ensures the CAPAs are effective and corrective/preventive for future deviations.
• Coordinates with process engineers/owners in the implementation of large equipment changes that impact the GMP manufacturing process.
• Leads risk mitigation activities required from Equipment Engineering.
• Participates in projects, technology transfer activities, risk assessments, and steering committees/boards associated with the cGMP manufacturing process as the Equipment Engineering SME.

 

Qualifications

• Undergraduate degree in Engineering or Life Science or 8 years direct, relevant experience in Bio/Pharmaceutical to provide a comparable background
• Minimum of 6+ years' experience in biopharmaceutical or healthcare industry

 

A Senior Equipment Engineer should have a strong mechanical background stemming from educational experience or industry experience. They should be very well acquainted with the systems used within the cGMP manufacturing process.

Proficient knowledge of Microsoft Office software, and other general office equipment.

Ability to learn and support new systems and applications, and the ability to provide technical training to end users.

In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)

Up-to-date with changes in technology and the business implications/applications of new technologies

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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