Process Engineer I

Descripción del trabajo

Under minimal supervision, the main accountabilities are focused on the front line technical support of manufacturing operations while closely collaborating with the Quality and Product Sciences Unit.

Responsibilities (include but are not limited to):

• Provides frontline MES support for manufacturing of cell therapy products

• Resolves routine manufacturing’s escalations

• Replicates issues and identifies corrective actions

• Ensures successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting MES related events

• In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools

  • Devises and implements CAPAs to address root cause and ensure effectiveness

  • Initiates deviations and Change controls

• Authors Root Cause Analysis, Change Controls and CAPAs (minor to moderate in complexity)

• Develops design requirements and designs processes in PAS-X (minor to moderate in complexity)

• Good understanding of design, MES system Life Cycle management, interface, troubleshooting and re-creation of minor to moderate in complexity issues

• Implements continuous design changes (minor to moderate complexity) that are required by the Business as a result of Change controls, CAPAs, Enhancements.

• Authors functional specifications, and test scripts (OQ/PQ) for the MES System Validation for minor to complex projects

• Develops Work Instructions and SOPs to support the MES system

• Authors minor to moderate Product impact assessments (IA) with minimal guidance.

• Performs OQ/ PQ, functionality testing

• Supports manufacturing through risk assessments (RA) and remediation measures (e.g. RA SME, technical SME, lead RA)

• Represents MES technical Operations in Site Change Control, CAPA and deviations meeting

• Leads minor to moderate projects in MES

• Supports regulatory inspections and may serve as SME

• Supports that development of training material and executes MES training activities on functionality and process changes and creation of SOPs

• Participates in the development of MES system life cycle strategy management

• Supports Commercial Process and Metrics Monitoring (e.g. data collection, verification)

• Participates in the implementation of different Projects in MES

• Identifies additional training or self-help improvement needs and communicates recommendations

• Requires general supervision from management

• Additional duties as assigned.

Requirements:

• BS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 2+ years of experience OR

• MS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 0+ years of experience

Preferred:

• Engineering degree preferred

• Cell culture, Cell therapy and/or aseptic processing experience

• Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions

• Experience with investigation and root cause analysis tools

• Skilled at creating and delivering presentations

• Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project

• Utilizes technical writing strategies to ensure content is clear and concise

• Possesses good communication skills

• Experience leading cross functional teams to obtain project deliverables

• Working knowledge of scientific and engineering principles

• Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus

• Knowledge of ERP systems implementation is desirable