Engineering Project Manager - Process Equipment (Raleigh)

Technical Source is seeking a Process Project Manager for our pharmaceutical client in the Raleigh, NC area. This role will lead the downstream stainless-steel equipment workstream for a large Drug Substance (DS) facility expansion. This is a true project management role focused on schedule, planning, and scope clarity —not a design engineering position. You will partner closely with the project scheduling team and cross-functional stakeholders to plan and drive the downstream work from design completion through FAT, SAT, commissioning, and qualification , ensuring readiness for equipment startup. Key Responsibilities Downstream Stainless-Steel Scope Act as project manager for a defined set of downstream stainless-steel DS systems , which may include: Stainless-steel chromatography skids Stainless-steel UF/DF systems Stainless-steel filtration systems Stainless-steel intermediate/hold tanks and transfer piping Relevant stainless-steel interfaces/utilities within defined system boundaries Project Management & Schedule Ownership Partner with the central scheduling / project controls team to own the downstream portion of the integrated project schedule . Define and sequence downstream tasks and dependencies from design completion → FAT → SAT → commissioning → qualification . Lead or drive downstream schedule reviews, highlighting risks, constraints, and required decisions. System Boundaries & Scope Clarification Work with engineering, automation, C&Q, operations, and vendors to define and maintain system boundaries for downstream equipment. Clarify what is in/out of scope for each team; ensure responsibilities are clearly assigned and documented. Identify and resolve scope gaps and ownership ambiguities before they impact FAT/SAT or startup. FAT/SAT Planning & Coordination Develop and maintain detailed FAT and SAT schedules for downstream stainless-steel systems with vendors and internal stakeholders. Ensure prerequisites (drawings, documents, automation integration, utilities readiness, staffing) are identified and scheduled. Track FAT/SAT readiness and execution; escalate risks that could affect downstream milestones. Gap Identification & Change Control Proactively identify planning and schedule gaps , missing tasks, or misaligned dependencies that could delay downstream startup. Participate in change control processes, providing assessment and documentation of downstream schedule and scope impacts (no direct cost/budget responsibility). Work effectively in a fast-paced, dynamic project environment with evolving design and execution needs. Required Qualifications Education & Experience (Aligned with client baseline plus PM/technical requirements) Bachelor’s degree in Engineering (Chemical, Mechanical, Process, or related) with 8+ years of engineering/project experience, OR Master’s degree with 6–8 years of experience, OR Associate’s degree with 10+ years of engineering experience. And: Significant experience as a Project Manager (not just an engineer) on capital projects in GMP biotech/pharma or a closely related regulated industry. Strong background with stainless-steel process equipment , preferably in downstream Drug Substance (chromatography, UF/DF, filtration, tanks). Technical & PM Skills Demonstrated experience owning a defined workstream within an integrated project schedule , in collaboration with project controls/scheduling. Solid understanding of downstream unit operations and how stainless-steel equipment is integrated into DS manufacturing (system-level understanding). Experience working with or defining system boundaries and cross-functional interfaces for process systems. Direct involvement in FAT/SAT planning and coordination for process equipment, including schedule creation/maintenance and readiness tracking. Participation in change control , especially evaluating and communicating schedule and scope impacts of design/scope changes. Soft Skills Strong ability to take loosely defined work and convert it into a clear, trackable plan. Effective communicator across engineering, automation, C&Q, operations, maintenance, vendors, and project controls. Comfortable both in the field and in meetings; verifies progress on the floor rather than relying only on reports. Detail-oriented, proactive, and able to thrive in a fast-paced, highly cross-functional project environment. Nice-to-Have Experience Experience with downstream commissioning and qualification (IQ/OQ/PQ) in a GMP environment. Familiarity with common biopharma automation platforms (e.g., DeltaV) sufficient to coordinate with controls engineers. Experience working directly with schedulers using Primavera, MS Project, or similar tools. Prior involvement in major pharmaceutical or biotech facility startups or expansions.