Position Details

Type Not Specified

Experience senior

Exp. Years 6+ years

Education Bachelor's Degree in Engineering, science, or closely related discipline (desired)

Category Engineering (Non-Software)

About this role

This Project Engineer role supports independently planned, high business impact engineering projects in Drug Product Manufacturing or Packaging. The engineer will manage project controls and reporting while serving as an SME during Regulatory Agencies Audits and ensuring cGMP-aligned risk mitigation through design, early risk assessments, and fallback strategies.

Key Responsibilities

Independently plan and conduct high business impact projects in Drug Product Manufacturing or Packaging
Develop execution strategy including procurement and balance multiple demands
Serve as Facility, Equipment, and Utilities SME during Regulatory Agencies Audits with documentation packages and presentations
Maintain project controls and reporting for cost, scope, and schedule
Mitigate risk through sound design, early risk assessments, and implementation of fallback strategies

Technical Overview

The role involves engineering design and execution strategy, including procurement planning, with strong emphasis on maintaining project controls for cost, scope, and schedule. It also requires technical responsibility for facility, equipment, and utilities audit readiness and applying risk assessment methods to anticipate defects and failure modes from design changes.

Ideal Candidate

The ideal candidate is a Project Engineer with at least 6+ years of significant engineering and/or operational experience, experienced in Drug Product Manufacturing or Packaging environments. They can independently plan and execute high business impact projects, support Regulatory Agencies Audits with documentation packages, and mitigate design-change risk using early risk assessments and fallback strategies.

Must-Have Skills

Drug Product ManufacturingDrug Product PackagingcGMP needsRegulatory Agencies Auditsrisk assessmentsfallback strategiesproject controlsprocurement

Required Skills

Drug Product ManufacturingDrug Product PackagingcGMP needsRegulatory Agencies AuditsFacilityEquipmentand Utilities SMEcompliance with applicable policies and proceduressound designearly risk assessmentsfallback strategiesproject controlscost scope and scheduleprocurementdocumentation packagesregulatory agentsengineering designsinternal and external consultantsdefects and failure modes

Hard Skills

Drug Product ManufacturingDrug Product PackagingcGMP needsRegulatory Agencies AuditsFacilityEquipmentand Utilities SMEdocumentation packagespresenting information to regulatory agentscompliance with applicable policies and proceduressound designearly risk assessmentsfallback strategiesdefects and failure modes analysisproject planninghigh business impact projectsexecution strategy including procurementprocurement planningproject controlsproject reportingcost scope and schedule reportingengineering designs for intermediate problemssystems integrationanalyzing complex interdisciplinary problemsprobability establishmentdraw conclusions reflecting broad business needsoversight of internal and external consultants

Soft Skills

works with little or no supervisionindependent planning and executionbalance multiple demandsrepresents engineering on corporate task forcescustomer/client needs identificationsolution proposal for customer needsmonitoring improvement of other engineersparticipate in evaluation of staff/project team membersmay supervise other engineers or techniciansrisk mitigation thinking

Industry & Role

Industry Manufacturing

Job Function Execute cGMP-aligned engineering projects for drug product manufacturing/packaging with audit SME support and risk-mitigating design execution

Role Subtype Manufacturing Engineer

Keywords for Your Resume

Project EngineerEngineering (Non-Software)Drug Product ManufacturingDrug Product PackagingcGMPcGMP needsRegulatory Agencies AuditsFacilityEquipmentand Utilities SMEcompliance with applicable policies and proceduressound designearly risk assessmentsfallback strategiesdefects and failure modesproject planninghigh business impact projectsexecution strategyprocurementproject controlscost scope and scheduledocumentation packagesregulatory agentsinternal and external consultantsengineering designs6+ yearsBachelors Degree in Engineeringpost-graduate educationrisk assessments

Deal Breakers

6+ years of significant engineering and/or operational experience, Experience in Drug Product Manufacturing or Drug Product Packaging, Demonstrated cGMP needs knowledge, Must be able to support Regulatory Agencies Audits with documentation packages

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