Lead Process Engineers & Managers - Project Farma

Project Farma is growing our Manufacturing & Tech Ops - Process Engineering practice, and will consider candidates' ranging from 5-15 years' relevant experience.

The successful candidate will reside within 50 miles of Raleigh, NC and be willing to travel domestically to meet client project requests.

Project Farma’s purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.

All team members are expected to embody Project Farma’s values by being curious
, personable
, and unselfish
, while maintaining a strong commitment to a Patient Focused and People First mindset
.

• Serve as the company’s Process Engineering Owner’s Representative throughout facility planning, conceptual design, basic design, detailed design, construction, commissioning, and qualification, as applicable.
• Provide day-to-day technical oversight of the A&E firm’s process engineering activities and deliverables.
• Establish expectations for process engineering scope, design criteria, deliverables, and technical standards.
• Review, challenge, and approve A&E process engineering deliverables on behalf of the Owner.
• Ensure A&E designs appropriately reflect the company’s User Requirements, process requirements, operational philosophy, and applicable engineering standards.
• Identify design gaps, inconsistencies, risks, and opportunities for optimization before they impact project cost, schedule, quality, or operability.
• Coordinate process engineering activities with architectural, mechanical, electrical, automation, structural, civil, environmental, and other engineering disciplines.
• Participate in design reviews, HAZOPs, risk assessments, constructability reviews, operability reviews, and value-engineering exercises.
• Ensure that design decisions are appropriately documented and technically justified.
• Monitor A&E performance against project scope, schedule, budget, and quality expectations.

Provide technical leadership and oversight for process design activities associated with one or more of the following practice areas:

• Sterile formulation and compounding
• Aseptic processing and filling
• Cleanroom and controlled-environment requirements
• Material and personnel flows
• Equipment and process skids
• CIP/SIP and sterilization processes
• Clean utilities and process gases
• Barrier technologies including RABS and isolators
• Single-use technologies
• Process equipment and facility integration

• Dispensing and material handling
• Milling, blending, granulation, drying, and compression
• Coating and encapsulation
• Tablet/capsule processing
• Containment and dust-control strategies
• Process equipment and material-transfer systems
• Packaging interfaces and manufacturing flows

• Bioconjugation and ADC process operations
• Highly potent compound handling and containment
• Antibody and linker-related process considerations
• Lipid nanoparticle formulation and processing
• Nanoparticle drug product operations
• Solvent handling and recovery considerations
• Containment, segregation, and personnel/material flow
• Single-use process technologies
• Process equipment and facility integration

• Primary and secondary packaging operations
• Drug-device combination…