Blackfield Associates

Manage product operations and technical support functions including cross-team collaboration, data analysis, and release readiness. | 8+ years in operations and technical support within SaaS environments, with skills in technical troubleshooting, data analysis, and product release support. | Blackfield Associates are currently partnered with a global pharmaceutical manufacturer to support their search for multiple Work package owners to join their project based in Virginia on an initial 12-month contract. Utilities Work Package Responsibilities • Oversee design, installation, and start‑up of clean and plant utilities critical to small‑molecule API production (e.g., purified water, clean steam, nitrogen, compressed air, process cooling, wastewater systems). • Review and approve utility engineering deliverables including P&IDs, equipment specifications, and tie‑in plans. • Coordinate utility interfaces with process systems, ensuring capacity, quality, and reliability requirements are met. • Support commissioning and qualification activities, ensuring utilities meet GMP readiness and performance criteria. Process Equipment Work Package Responsibilities • Manage the delivery, installation, FAT/SAT, and commissioning of API‑related process equipment, such as reactors, filtration systems, dryers, centrifuges, blending equipment, and solvent handling vessels. • Ensure process equipment design supports small‑molecule chemistry operations, batch sequences, operator safety, and process safety requirements. • Coordinate vendor documentation, design reviews, installation oversight, and technical issue resolution. • Interface closely with automation, utilities, and process engineering to ensure equipment integration and operability. Solvent Recovery Work Package Responsibilities • Lead the installation and commissioning of solvent recovery systems, including distillation columns, condensers, storage tanks, and solvent waste handling equipment. • Ensure solvent recovery processes comply with process safety standards, flammable area classifications, emissions controls, and environmental permitting requirements. • Support hazard assessments (e.g., HAZOP, PHA) and incorporate safety recommendations into design and execution. • Verify system performance against recovery efficiency, purity, and throughput targets. Experience Required • Sufficient engineering experience within pharmaceutical, chemical, or API manufacturing projects. • Proven experience delivering work packages in utilities, process equipment, and/or solvent recovery systems. • Strong understanding of small‑molecule API production processes, facility utilities, and solvent‑based operations. • Demonstrated experience managing vendors, contractors, and cross‑functional engineering teams. • Solid knowledge of GMP requirements, process safety principles, and mechanical/chemical engineering fundamentals. • Strong problem‑solving and coordination abilities, with the capability to manage multiple technical scopes simultaneously. • Bachelor’s degree in Chemical, Mechanical, Process Engineering or equivalent discipline.