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

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 other relevant standards and industry practices into engineering decisions.

Work closely with Quality, Manufacturing, Validation, Regulatory, EHS, and Operations functions.

Ensure appropriate consideration of CQAs, CPPs, contamination-control strategies, cleaning, sterilization, aseptic processing, containment, and cross-contamination risks.

Support development and review of qualification and validation strategies as they relate to process and equipment design.

Participate in regulatory inspection readiness activities where engineering support is required.

Project Execution

Represent Global Engineering in project meetings with internal stakeholders, A&E firms, equipment vendors, contractors, and other project partners.

Track technical issues, design decisions, action items, and engineering risks.

Escalate significant technical, schedule, cost, or quality risks to project and engineering leadership.

Support project change management and assess the technical impact of proposed changes.

Participate in FATs, SATs, commissioning, startup, and qualification activities as appropriate.

Support resolution of construction and commissioning issues related to process systems and equipment.

Ensure final engineering documentation accurately reflects the installed facility and equipment.

Attributes for Success

Technical Delivery: Applies advanced technical knowledge and professional expertise

Innovation & Continuous Improvement: Seeks better ways, adapts to change and champions new ideas.

Customer Focus & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations

Integrity & Humility: Demonstrates self-awareness and puts PF mission above ego

Collaboration & Communication: Communicates clearly and proactively and drives transparent alignment with clients.

Project Execution: Delivers reliably, manages priorities and drives for high quality outcomes

Growth Mindset: Shows openness to new ideas, feedback and change

Experience Required

Required Qualifications

Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience.

Approximately 5–10 years of relevant pharmaceutical, biotechnology, or life-sciences engineering experience.

Demonstrated experience with pharmaceutical or biotechnology facility design, process engineering, or capital project execution.

Experience working with or managing Architecture & Engineering firms and/or engineering contractors.

Demonstrated ability to function effectively as an Owner’s Representative.

Strong understanding of GMP manufacturing environments and pharmaceutical engineering practices.

Ability to independently review and challenge process engineering deliverables.

Experience developing or reviewing PFDs, P&IDs, equipment specifications, layouts, process descriptions, and utility requirements.

Strong understanding of the relationship between process requirements and facility design.

Excellent written, verbal, organizational, and interpersonal communication skills.

Ability to manage multiple priorities in a global, matrixed organization.

Willingness to travel as required for client project assignments.

Other Preferred

Experience in one or more of the following:

Sterile drug product manufacturing

Aseptic processing

Oral solid dosage manufacturing

ADC manufacturing

High-potency API or drug-product containment

Lipid nanoparticle manufacturing

Drug-device combination products

Automated packaging and inspection systems

Experience with RABS, isolators, single-use systems, CIP/SIP, sterilization, or clean utilities.

Experience with process equipment selection and vendor management.

Experience participating in HAZOP, FMEA, design qualification, commissioning, and qualification activities.

Familiarity with ISPE Baseline Guides and Good Practice Guides.

Familiarity with FDA and EU GMP expectations for pharmaceutical manufacturing facilities.

Experience working on international projects and with globally distributed engineering teams.

Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.

The annual compensation range for this full-time position is $(74,000) to $(113,000). The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.