Life Sciences Engineering Consulting
Comprehensive pharmaceutical engineering solutions for biopharma manufacturers throughout the Research Triangle and nationwide. From conceptual design through facility startup, Sequence delivers compliance, efficiency, and innovation at every stage.
End-to-End Pharmaceutical Engineering Excellence
We support our clients through every stage of pharmaceutical facility startup and process development, ensuring GMP compliance, operational efficiency, and technical innovation for highly regulated life sciences environments.
Our multidisciplinary engineering team coordinates seamlessly with stakeholders, manages complex timelines and budgets, and ensures alignment with FDA, EU GMP, and ISPE regulatory standards. From detailed design reviews through final turnover, we provide the technical expertise and oversight needed to bring your vision to life.
Combined with our commissioning, qualification, and validation (CQV) capabilities and computer system validation expertise, Sequence offers a truly integrated engineering consulting solution for life sciences manufacturers.
Five Core Pharmaceutical Engineering Disciplines
Engineering Project Management
Comprehensive oversight and engineering input across all project phases, ensuring seamless execution from detailed design through final turnover for pharmaceutical and biopharma facilities.
- Provide oversight and engineering input in all phases from Detailed Design through Turnover
- Coordinate multidisciplinary teams, manage timelines, budgets, and resources
- Ensure alignment with regulatory standards and client objectives
- Facilitate communication among stakeholders to deliver projects on time and within scope
Startup & Commissioning
Systematic commissioning and startup support ensuring safe, efficient facility energization and operational readiness for GMP manufacturing environments.
- OEM Vendor oversight and coordination
- LOTO and safety walkdowns
- Charge and purge distribution lines
- Passivation & blowdown strategies
- Energization strategies
- Commissioning test plan development and execution to be leveraged for qualification
Pharmaceutical Process Engineering
Detailed technical review and validation of process systems, from drawing reviews through component installation verification for life sciences manufacturing.
- Drawing reviews
P&IDs
Riser Diagrams
Isometric drawings
- Component selection and data sheet reviews
- Component installation and construction inspections (Piping, Tagged Components)
- URS Development
- OEM Vendor coordination & procurement support
Automation Engineering
Advanced automation solutions including infrastructure design, platform selection, and detailed configuration specifications for pharmaceutical manufacturing systems.
- FRS Development
- Infrastructure Design and Platform Selection
- Detailed Design reviews and configuration specifications
- IT/OT Integration
Instrumentation & Controls
Complete instrumentation lifecycle management from selection through calibration certification and criticality assessment for regulated manufacturing environments.
- Instrument selection and data sheet reviews
- Instrument classification and Criticality Assessments
- Instrument installation verification
- Wiring/loop diagram walkdowns and loop checks
- Calibration certification
- Asset Data Readiness
Experienced Life Sciences Engineering Team, Proven Results
Our multidisciplinary engineering professionals bring decades of combined experience in pharmaceutical facility design, startup, and optimization across the Research Triangle and nationwide.
- Cross-functional pharmaceutical engineering expertise
- GMP and regulatory compliance specialists
- Advanced technical documentation and design reviews
- OEM vendor coordination and management
- Risk-based engineering approaches aligned with ISPE and FDA guidelines
Systematic, GMP-Compliant Engineering
Every project follows our proven systematic process, ensuring nothing is overlooked and all deliverables meet the highest standards of pharmaceutical quality and regulatory compliance.
From initial design reviews through final commissioning and startup, our team brings structured methodologies and deep technical expertise to every life sciences engineering engagement.
Aligned with Global Pharmaceutical Standards
ISPE Baseline Guides
Engineering practices aligned with ISPE industry best practices for pharmaceutical facility design and operation
FDA 21 CFR Part 11
Full compliance with electronic records and electronic signature requirements for regulated systems
EU GMP Annex 15
Qualification and validation aligned with European pharmaceutical manufacturing requirements
GAMP 5
Risk-based approach to computerized system validation and automation lifecycle management
ASME BPE
Bioprocessing equipment standards for hygienic design and construction in biopharmaceutical facilities
cGMP Requirements
Current good manufacturing practices ensuring product quality, safety, and regulatory compliance
Ready to Start Your Pharmaceutical Engineering Project?
Partner with Sequence for comprehensive life sciences engineering consulting that ensures compliance, efficiency, and success for your pharmaceutical facility — from the Research Triangle to sites nationwide.
Get Started Today →