Sanofi
More than three decades of direct vendor support across validation, MSAT, facilities, utilities, equipment, data integrity, decommissioning, and quality oversight.
01Regulated manufacturing
Execution engineered for complex operations.
Process Core Engineering connects MSAT, process engineering, CQV, quality, and project delivery to move pharmaceutical and biotechnology programs from technical challenge to site readiness.
30+Years supporting Sanofi Toronto
7Connected technical disciplines
360Lifecycle coverage
24/7Operational readiness mindset
02What we bring
Technical depth without delivery gaps.
For more than three decades, Process Core Engineering has supported Sanofi Toronto directly as a vendor and service partner across manufacturing systems, facilities, utilities, validation, and capital projects.
Our teams integrate with Process Development, Manufacturing, Quality, Supply Chain, Regulatory, and Engineering to convert requirements into coordinated, compliant execution.
03Technical index
Services built around the manufacturing lifecycle.
Open each discipline for representative scope. Engagements can be focused or integrated across a full program.
01MSAT & process engineeringRobustness / scale-up / lifecycle
- Process robustness, troubleshooting, and sustained performance.
- Scale-up, comparability, process changes, and lifecycle optimization.
- PPQ strategy, execution support, continued process verification, and data review.
- Technology transfer from development and pilot scale to commercial manufacturing.
- Bioreactors, CIP/SIP, formulation, buffer preparation, filtration, chromatography, and fill-system integration.
02Project management & deliveryControls / risk / readiness
- End-to-end management for MSAT and process initiatives.
- Critical-path scheduling, look-ahead planning, and readiness coordination.
- Cost tracking, forecasting, scope, change, risk, and issue control.
- Vendor coordination and stakeholder communication.
03Commissioning, qualification & validationFAT / SAT / IOQ / PQ
- Full lifecycle CQV strategy, execution, oversight, and continued verification.
- Deviation, RCA, CAPA, remediation, and requalification.
- Process, utility, equipment, fill-finish, and packaging qualification.
- Audit readiness aligned with cGMP and applicable FDA, EMA, and Health Canada expectations.
04Fill, fill-finish & packagingAseptic / inspection / packaging
- Sterile and non-sterile filling support for vial, syringe, cartridge, and bottle lines.
- Isolators, RABS, washers, depyrogenation, sterilization, and inspection.
- Labelling, serialization, cartoning, case packing, and palletizing.
- Capacity expansion, replacement, upgrades, and obsolescence management.
05Facilities, utilities & cleanroomsControlled environments / utilities
- ISO-classified environments, HVAC zoning, pressure cascades, airflow, and qualification.
- WFI, purified water, clean steam, process gases, compressed air, and nitrogen.
- Chilled water, hot water, boilers, cooling towers, electrical distribution, and thermal systems.
- Optimization, decommissioning, repurposing, and recommissioning.
06Quality, GMP & complianceGovernance / documentation / integrity
- GMP governance of MSAT, process, and engineering execution.
- Protocols, reports, validation documentation, and training materials.
- Batch record review, data integrity, process improvement, and audit readiness.
07Digitalization & advanced engineeringPLC / DeltaV / data
- Automation and controls expertise, including PLC and DeltaV platforms.
- Digital tools supporting MSAT efficiency, data analysis, and validation.
- CAD, data-driven commissioning, and software-enabled optimization.
04Delivery model
Four controls. One operating objective.
- 01Technical definition
Clarify the process, compliance, schedule, and business outcomes.
- 02Integrated planning
Connect disciplines, interfaces, quality systems, and readiness milestones.
- 03Controlled execution
Manage scope, risk, vendors, documentation, and field delivery.
- 04Verified sustainment
Transfer knowledge, confirm performance, and support continued control.
05Relevant experience
Work shaped inside demanding regulated environments.
FUJIFILM Diosynth
MSAT, engineering, and capital-project execution within large-scale biologics manufacturing programs.
Pfizer
Turnkey API and biologics process equipment and utilities from design through commissioning and validation.
Broad industry
Additional experience across Merck, Eli Lilly, Amgen, Lonza, Biogen, GSK, and other regulated organizations.
Organization names describe relevant project experience. No endorsement, sponsorship, or affiliation is implied.
06Project inquiry
Put the next milestone in motion.
Tell us about the process, equipment, facility, or program challenge. We will respond with the right technical conversation.
Contact directly