Manufacturing & Tech Ops - Process Engineer III/Lead Process Engineer - Project Farma

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

Job Title

Manufacturing & Tech Ops - Process Engineer III/Lead Process Engineer - Project Farma

Location(s)

Customer Site - CA, Customer Site - CO, Customer Site - OR, Customer Site - TX, Pasadena, CA, San Diego, CA, South San Francisco, CA

Job Description

The successful candidate will reside in one of Project Farma's primary markets 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.

The Manufacturing & Tech Ops – Process Engineer III / Lead Process Engineer is an advanced individual contributor with demonstrated depth in their technical discipline and a growing record of leading complex workstreams. This role applies strong subject‑matter expertise to solve high‑impact technical and operational challenges, supports technical decision‑making, and contributes to the evolution of standards, methods, or best practices within their area. The Lead Engineer works with a high degree of independence, mentors junior and peer engineers, and partners closely with project and people leaders—while remaining focused on technical delivery rather than formal people management.

Key Responsibilities

The Process Engineer III / Lead Process Engineer will participate in clients’ Global Engineering teams as an Owner’s Representative supporting the development and execution of pharmaceutical and biotechnology capital projects.

This role will serve as a complementary extension of the company’s internal engineering organization, providing technical leadership, project oversight, and process engineering expertise while working closely with internal stakeholders and external Architecture & Engineering (A&E) firms.

The Process Engineer III / Lead Process Engineer will be responsible for overseeing the process design performed by A&E firms working on projects, ensuring that process concepts, user requirements, equipment selections, facility layouts, utilities, process flows, and engineering deliverables align with the company’s operational, technical, quality, regulatory, and business objectives.

The successful candidate will have sufficient technical depth to challenge and guide A&E design teams while also possessing the communication, coordination, and project-management skills necessary to operate effectively within a global engineering organization.

Key Responsibilities

Owner’s Representative / A&E Oversight

• •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.

Process Design

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

Sterile Drug Product

• •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
• •Oral Solid Dosage
• •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
• •Antibody Drug Conjugates / Lipid Nanoparticles
• •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
• •Device & Packaging / Inspection Systems
• •Primary and secondary packaging operations
• •Drug-device combination products
• •Automated packaging equipment
• •Device assembly and integration
• •Serialization and aggregation systems
• •Vision inspection and automated inspection systems
• •Container closure and packaging-line integration
• •Material handling and automation interfaces
• •Line clearance and product changeover considerations

Engineering & Technical Leadership

• •Translate process requirements into practical facility and equipment design requirements.
• •Develop and/or review Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), equipment specifications, equipment layouts, process descriptions, and process design criteria.
• •Review equipment sizing, process calculations, material balances, utility requirements, and equipment data sheets.
• •Establish and review process and equipment design assumptions.
• •Ensure appropriate consideration of GMP, EHS, containment, ergonomics, maintainability, reliability, operability, and lifecycle requirements.
• •Evaluate proposed technologies and equipment against process requirements and lifecycle objectives.
• •Identify opportunities to improve process robustness, flexibility, maintainability, and operational efficiency.
• •Support technical evaluations of equipment suppliers and technology providers.
• •Provide technical input into capital cost estimates and project schedules.

GMP, Quality, and Regulatory

• •Ensure process designs support applicable GMP requirements and regulatory expectations for pharmaceutical and biotechnology manufacturing.
• •Incorporate applicable FDA, EMA, EU GMP, ICH, ASTM, ISPE, and oth