Manufacturing engineer Jobs in Pittsburgh, PA

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

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About Kelly

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