Senior Project Engineering Manager – Pharmaceutical, Construction

Cumming Group

. Provide owner-side technical oversight of pharmaceutical facility design and engineering .

Posted 9/21/2026full-timeUnited StatesSenior💰 $121,200 - $169,667 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge in cGMP pharmaceutical facility design and engineering, with a strong focus on process systems, clean utilities, and regulatory compliance. Proven ability to oversee technical design reviews, ensuring alignment with FDA and EMA standards while supporting operational readiness and quality assurance.

Highest-signal resume keywords

CGMP Pharmaceutical Facility DesignProcess Systems KnowledgeTechnical Lead ExperienceCQV and Quality by DesignProfessional Engineer Registration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmaceutical EngineeringProcess Flow DiagramsP&IDsHVAC DesignCleanroom DesignAutomation SystemsContamination ControlMaterial HandlingEngineering SpecificationsValidation Requirements

Certifications & Qualifications

Professional Engineer Registration

Industry Keywords

CGMP ComplianceFDA ExpectationsEMA ExpectationsISPE GuidanceASME BPENFPA StandardsGreenfield DesignConstruction ManagementDesign Risk AssessmentsOperational Readiness

About the role

Key responsibilities & impact

Provide owner-side technical oversight of pharmaceutical facility design and engineering
Review concept, basic design, detailed design, vendor, and construction packages for technical and cGMP compliance
Confirm user, manufacturing, operational, validation, and regulatory requirements are incorporated into design
Review process, mechanical, piping, HVAC, cleanroom, electrical, automation, utility, laboratory, warehouse, and support-building designs
Review process and clean utility systems, including purified water, water for injection where applicable, clean steam, process gases, compressed air, HVAC, and waste systems
Evaluate personnel, material, waste, equipment, and product flows
Review room classifications, pressure cascades, zoning, containment, environmental conditions, and hygienic design
Review equipment layouts, P&IDs, utility requirements, specifications, and control philosophies
Coordinate technical interfaces across manufacturing buildings, central utilities, laboratories, tank farms, warehouses, and infrastructure
Identify design gaps, technical conflicts, constructability issues, and GMP risks
Support HAZOPs, process hazard analyses, design-risk assessments, and technical change control
Confirm designs support commissioning, qualification, cleaning, maintenance, operation, and future expansion

Requirements

What you’ll need

cGMP pharmaceutical facility design and engineering knowledge
Knowledge of API, peptide, biologics, monoclonal antibody, bioconjugate, or comparable manufacturing processes
Knowledge of process systems, clean utilities, HVAC, cleanrooms, laboratories, automation, and material handling
Knowledge of contamination control, segregation, containment, hygienic design, and cleanability
Knowledge of process flow diagrams, P&IDs, equipment layouts, utility diagrams, control narratives, and engineering specifications
Knowledge of FDA and EMA expectations, ISPE guidance, ASME BPE, NFPA, and applicable engineering standards
Knowledge of CQV, Quality by Design, data integrity, process safety, and operational readiness
Bachelor's degree in Chemical, Mechanical, Process, Biochemical, or Pharmaceutical Engineering preferred
12+ years of pharmaceutical engineering or capital-project experience
5+ years in a Technical Lead, Engineering Lead, Design Manager, or GMP Lead role
Greenfield cGMP design, construction, CQV, and startup experience
Professional Engineer registration preferred

Benefits

Comp & perks

Medical
Dental Insurance
Vision Insurance
401(k)
401(k) Matching
Paid Time Off
Paid Holidays
Short and long-term disability
Employee Assistance Program