3 Key Consulting, Inc. · 4 months ago
Engineer Senior, Project Implementation, New Equipment & Continuous Improvement - (JP14460)
3 Key Consulting, Inc. is hiring an Engineer Senior for a consulting engagement with a leading global biopharmaceutical company. The role provides engineering support for projects and manufacturing activities, focusing on project implementation, continuous improvement initiatives, and system reliability.
AdviceCloud ComputingInformation TechnologyStaffing Agency
Responsibilities
Working in close collaboration with system owners, project teams, and cross-functional stakeholders
Partner with system owners, maintenance, project management, and manufacturing to ensure reliable operation and execution of equipment and systems
Lead or support engineering-based improvements and capital projects, including requirements definition, design, construction, startup, and validation
Drive continuous improvement by applying Lean principles, Six Sigma, and other methodologies to reduce costs, improve quality/safety, and increase operational efficiency
Support commissioning, qualification, and performance verification activities for equipment and systems
Provide oversight into contractors and vendor deliverables and ensure adherence to company standards
Act as liaison between Engineering and Manufacturing during project planning, execution, and closeout
Provide technical root cause analysis, troubleshooting, and problem-solving support to minimize downtime
Support new product/technology introductions through engineering assessments and equipment modifications
Ensure compliance with environmental health, safety, and regulatory requirements during all engineering activities
Deliver coaching and guidance to project teams on commissioning, qualification, and process risk-based approaches
Qualification
Required
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR associate's degree and 8 years of experience OR High school diploma / GED and 10 years of experience
Technical report writing, documentation, and presentations
Strong verbal and written communication
Organizational and change management skills
Analytical problem-solving and scientific/engineering reasoning
Experience with systems such as Maximo, TrackWise, E-Builder, PCS, BMS, and QEMS
Ability to manage multiple projects and troubleshooting activities simultaneously
Basic project management and cost estimation skills
Conflict resolution and cross-functional collaboration
Contractor and vendor management
Development of SOPs and training delivery
Customer service in a technical environment
Continuous improvement methodologies (Lean, Six Sigma, SPC, Predictive Maintenance)
Preferred
Bachelor's degree in chemical, Mechanical, Electrical, or related Engineering field
6+ years of relevant engineering experience, with at least 5+ years in a biopharmaceutical or regulated manufacturing environment
Experience working in compliance-driven settings (e.g., cGMP, OSHA, EPA)
Direct knowledge of design, operation, and troubleshooting of GMP production equipment (e.g., chemical reactors, chillers, tablet press, dosage, clean utilities, etc.)
Demonstrated ability to apply engineering principles to system modifications, process improvements, and capital project execution
Knowledge of safety requirements and quality systems in a biopharmaceutical environment (change control, deviations, CAPA, validation)
Proven ability to lead and collaborate within cross-functional project teams
Strong leadership, technical writing, and presentation skills
Independent, self-motivated, organized, and able to adapt to dynamic project environments
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageRecent News
2025-09-29
Company data provided by crunchbase