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.

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

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 $90,000 - $175,000. 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.