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.