This is a full-time salaried position with Project Farma, a PerkinElmer company. 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 - Engineer III is an experienced technical leader who serves as a subject-matter expert and drives complex workstreams from planning through execution. This role applies advanced technical expertise and strong understanding of project objectives to solve complex problems, influence technical direction, and deliver high-quality outcomes. These Engineers independently lead workstreams, proactively identify risks and improvement opportunities, and ensure alignment with client and business expectations. They act as trusted advisors to project teams and stakeholders while demonstrating leadership through mentorship, quality ownership, and cross-functional collaborations. This role requires strategic problem-solving, sound judgement, and a high level of accountability in driving results.
Key Responsibilities
The Manufacturing & Tech Ops - Engineer III serves as the technical subject matter expert responsible for supporting the commercial manufacture, technology transfer, process validation, process optimization, and lifecycle management of biopharmaceutical manufacturing processes. This position acts as the primary technical interface between Process Development, Manufacturing, Quality, Engineering, Regulatory Affairs, Supply Chain, and external manufacturing partners to ensure robust, compliant, and efficient production operations.
The Manufacturing & Tech Ops - Engineer III provides scientific leadership for troubleshooting manufacturing issues, evaluating process performance, implementing process improvements, supporting investigations, and ensuring manufacturing processes remain in a validated state throughout the product lifecycle. The individual applies scientific principles, engineering knowledge, statistical analysis, and quality risk management to improve manufacturing robustness while maintaining regulatory compliance and product quality.
Primary Responsibilities
Manufacturing Support
Provide technical support to GMP manufacturing operations for clinical and commercial products.
Serve as the primary technical contact during manufacturing campaigns.
Evaluate process performance and recommend improvements to increase robustness, yield, and process capability.
Support manufacturing deviations, nonconformances, and investigations by identifying root causes and implementing effective corrective and preventive actions (CAPA).
Assess manufacturing trends and identify opportunities for continuous improvement.
Process Validation
Develop and execute process validation strategies, including process validation master plans (PVMP), process performance qualification (PPQ), continued process verification (CPV), and lifecycle validation activities.
Author and review validation protocols and reports.
Evaluate validation data using statistical tools and process capability analyses.
Support qualification of new manufacturing equipment and process changes.
Understanding of general process validation requirements for FDA and EMA.
Technology…