Title: Process Engineer Contractor – Automation of Machinery and Processes (AMP) Team (29481)
Start Date: ASAP
Duration: 12 Months
Logistics: Fully Onsite – candidate may choose homebase between Boston and Providence but will need to have occasional presence at both sites
Hours/week: 40 hours/week
Bill Rate: $130 p/h (43% markup)
Manager Notes:
• Experience with FMEA, root cause analysis, CAPA, and change control is required
• Must have GMP-regulated cell & genetic therapy industry experience
• Looking for candidate with strong execution mind-set and strong communication skills, must be confident in engineering mindset
Process Engineer Contractor – Automation of Machinery and Processes (AMP) Team
Are you ready to revolutionize Cell & Gene Therapy? Join us in shaping the future of therapeutics! We are seeking a Process Engineer Contractor in our journey of developing cutting-edge manufacturing solutions for Casgevy—a first-of-its-kind therapy transforming the treatment of Sickle Cell Disease and Beta Thalassemia. In this role, you will be at the forefront of automating complex processes in one of the most dynamic and rapidly evolving fields in biotechnology. You will work with a passionate team of scientists, engineers, and innovators, all united by a shared mission: to push the boundaries of what’s possible in Cell & Genetic Therapy. This position will play a critical role in equipment & systems development, process optimization, and technology transfer to ensure robust and reliable systems that advance our mission. The position is onsite 5 days per week at Providence, RI and/or Boston, MA sites with ad-hoc flexibility.
Key Responsibilities:
- Process & Systems Engineering Expertise: Provide technical support for the design, specification, selection, and lifecycle management of cell & genetic therapy process equipment and manufacturing systems, ensuring alignment with program objectives, business needs, regulatory requirements, and industry standards.
- Process Equipment & Manufacturing System Ownership: Serve as a subject matter expert for cell & genetic therapy process equipment and manufacturing systems during requirements definition, design reviews, commissioning, qualification, validation, and ongoing manufacturing support. Guide teams through complex technical decisions and issue resolution.
- Process & Equipment Optimization: Support high-impact initiatives to improve equipment reliability, process robustness, operational efficiency, and scalability. Advance implementation of engineering solutions through structured problem-solving, risk assessment, and change management.
- Technical Delivery: Support engineering workstreams and complex equipment development efforts from concept through implementation, including URS/FRS development, technology evaluations, facility & systems simulation, requirements mapping, safety risk assessments, FMEA execution, study design, FAT/SAT execution, technology transfer, and validation support. Collaborate with and manage external vendors to deliver systems on time and within budget.
- Troubleshooting and Manufacturing Support: Provide advanced hands-on technical support for equipment and manufacturing operations, including troubleshooting critical issues, supporting rapid development cycles, and enabling long-term manufacturing sustainability.
- Documentation and Compliance Excellence: Author, review, and approve technical documentation including protocols, reports, SOPs, work instructions, specifications, and engineering assessments, ensuring compliance with regulatory, quality, and internal standards.
- Cross-Functional Influence and Collaboration: Partner closely with Manufacturing, Process Development, Quality, Validation, Facilities, MSAT, Project Management, and external vendors/partners to ensure successful delivery of engineering and equipment initiatives across the product lifecycle.
- Deviation, CAPA, and Change Control Leadership: Lead and support complex investigations, root cause analyses, deviation assessments, CAPA development, and change control activities. Ensure timely closure and sustainable corrective actions.
- Technical Development: Contribute to the development of engineering best practices, standard work, and technical capabilities across the organization.
- Execution and Accountability: Deliver assigned objectives on time and within budget while proactively identifying risks, escalating issues, and communicating impacts and mitigation plans to stakeholders and leadership.
- Quality and Regulatory Compliance: Ensure all activities are executed in accordance with applicable regulatory requirements, corporate policies, and Quality System expectations.
- Additional Responsibilities: Perform other duties as assigned based on business and program needs.
Required Qualifications:
- Education: BS or MS in Engineering or a related technical discipline.
- Experience: 7+ years of relevant experience with a BS, or 5+ years of relevant experience with an MS, in process engineering, systems engineering, project engineering, equipment engineering, and/or process optimization within the GMP-regulated cell & genetic therapy industry.
- Process & Systems Engineering: Demonstrated experience leading complex equipment and manufacturing systems development initiatives from concept through implementation, including requirements definition, design, specification, documentation, commissioning, qualification, validation, and lifecycle support. Cell & genetic therapy experience desired.
- Technical Communication: Excellent technical writing, presentation, and communication skills, with the ability to clearly convey complex engineering concepts to technical and non-technical stakeholders.
- Regulatory Knowledge: Strong understanding of cGMP/cGxP principles and practices, including familiarity with 21 CFR Part 210 and 211 and applicable engineering and validation expectations in regulated manufacturing environments.
- Problem Solving and Risk Management: Proven success applying structured problem-solving and risk-based decision-making to resolve technical challenges. Experience with FMEA, root cause analysis, CAPA, and change control is required. Lean/Six Sigma Green Belt or DMAIC experience preferred.
- Independence and Influence: Ability to operate with a high degree of autonomy, exercise sound engineering judgment, and influence decisions across functions and organizational levels.
- Collaboration and Leadership: Strong interpersonal and leadership skills with a demonstrated ability to manage multiple priorities, coordinate cross-functional and external contributors, and drive execution across complex programs.
Execution Mindset: Strong sense of urgency, accountability, and proactive escalation, with the ability to balance strategic thinking and hands-on execution.
Pay: $75.00 - $80.00 per hour
Work Location: In person
