BioSpace · 3 days ago

Process Engineer

Waco, TX

Full-time

Onsite

Entry Level

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Comp. & Benefits

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Responsibilities

Plans and conducts small-to-medium size assigned projects within engineering specialty.

Coordinates and monitors activities/projects, reviews plans, and monitors status of implementation.

Estimates and coordinates resources needed to accomplish assigned tasks.

Independently executes the design of products/processes/equipment/systems/facilities.

Improves methods/designs/processes and mentors others by sharing technical expertise.

Directs the efforts of others such as technicians and outside resources.

Performs tasks such as writing requests for Capital Expenditures (RCEs), safety/quality checklists, scope documents, etc.

Develops and executes validation protocols.

Qualification

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ValidationsGMP RegulationsFDA RegulationsPharmaceutical ManufacturingMedical DevicesWater SystemsClean RoomsAseptic ProcessingPackagingSterilizationLaboratory EquipmentComputer Systems ValidationControlled EnvironmentSurgical MaskGogglesGowning CertificationsAseptic Processing OperationsMS Office

Required

Bachelors Degree in Engineering, Science, or closely related discipline is desired

2+ years of relevant significant engineering and/or experience with an emphasis in validations

Experience working in a GMP regulated environment

Knowledge of FDA regulated industrial environment, preferred

Experience in the manufacturing of pharmaceutical or medical devices with knowledge of validation water systems, clean rooms, aseptic processing operations, packaging, sterilization, laboratory equipment, and computer systems validation

Able to work in a controlled environment that includes surgical mask and goggles

Ability to comply with gowning certifications and subsequent gowning verifications