Job Description

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.