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Abbott · 3 months ago

Manufacturing Process Engineer II

United States - Indiana - Westfield

Full-time

Onsite

Mid Level

$60K/yr - $120K/yr

3+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Manufacturing Process Engineer II role focuses on improving manufacturing processes and equipment quality while participating in new product design to enhance efficiency and reduce costs.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Develops processes based on product specifications and in consideration to process and test method capabilities

Evaluates process and design alternatives based on Design for Manufacturability (DFM) principles

Uses problem solving and statistical tools and make sound design recommendations

Manages program compliance with Quality requirements (i.e. Design Control, Process validation etc.)

Can identify work environment issues (i.e. OSHA regulations, etc.)

Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Conducts tests, collects and formats data, and assists in analysis of engineering studies (DOEs)

Assists in start up of new equipment and execution of validation protocols

Participates in technical design reviews for process equipment and product design and requirements documents

Responsible for utilizing and maintaining the effectiveness of the quality system, including supporting Quality Incidents and CAPA investigations and actions

Analyzes raw material specifications to ensure appropriate features and limits are in place to support company manufacturing process

Evaluates company initiated raw material changes and coordinates appropriate testing and validation as required

Works to reduce costs in all areas of manufacturing by analyzing current equipment for process suitability and provides detailed plans for improvement

Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to insure compliant, efficient, and safe processes

Conducts preventative maintenance audits and compliance with SOPs, ISO, FDA and cGMP requirements

Researches engineering solutions to a diverse set of challenges in production and development

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Qualification

Manufacturing Process EngineeringStatistical AnalysisQuality Management SystemsData AnalyticsCADCGMP RegulationsISO 13485MultitaskingVerbal CommunicationWritten CommunicationTeamworkProblem SolvingSelf-Motivated